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Continuing the Regulations.gov documents list, 1000 records per page, after FDA-2015-H-0130-0001.

1. FDA-2023-E-1527-0007Letter to U.S. Patent and Trademark Office
2. FDA-2017-H-3733-0001CMP Complaint Issued to Isabella Fuels Corp. d/b/a Shell
3. FDA-2011-N-0003-0079Oral Dosage Form New Animal Drugs: Phenylpropanolamine
4. FDA-2004-N-0240-0002Notice of Correction re Requirements Pertaining to Sampling and Private Laboratories Used…
5. FDA-1977-N-0002-1217Answer Letter from FDA/Office of Legislative Services to Honorable Hubert H. Humphrey…
6. FDA-2022-N-2390-0351Exhibit 28 - Complete Response Letter (Aug. 16, 2019)
7. FDA-2010-V-0375-0002Acknowledgement Letter to Respond Systems Incorporated
8. FDA-1997-S-0039-0997Wellness & Nutrition India Pvt Ltd. - Executives Nutrition for Daily Wellness - Magnesium…
9. FDA-2025-H-1647-0001Complaint
10. FDA-2014-N-1051-0730729 7694105 Survey Subject R4039_Redacted
11. FDA-2024-H-5590-0001Complaint
12. FDA-2025-S-0024-10122025-001100 - Gaia Herbs Inc - Gaia Herbs, Agile Mind 60 Liquid Phyto-caps Herbal…
13. FDA-2019-P-1636-0003Annexure I: Copy of Orange Book current through March 2019, listing the subject…
14. FDA-2003-N-0382-0004Supporting Statement for Food Additive Petitions
15. FDA-2022-E-2023-0006Letter from U. S. Patent and Trademark Office
16. FDA-2011-S-0932-07834Life Research U. S. A., L. L. C. (Transfer Factor Cardio Supplements) Supports Healthy…
17. FDA-2017-H-5470-0001Complaint
18. FDA-2024-E-5009-0003Letter from FDA CDER to U. S. Patent and Trademark Office
19. FDA-1990-S-0006-0054Statistical Report for December 2003
20. FDA-2015-N-3469-0024Nomination from Sincerus Florida, LLC
21. FDA-1977-N-0014-1312Answer from FDA/Center for Veterinary Medicine to Comment from Allen Taylor, M.D.
22. FDA-2012-S-1144-0473NBTY, Inc. - Calcium Citrate + D3 supplements under the Kroger label - Bone Supplement
23. FDA-2016-N-3120-0020redacted_004_091695 Bioequivalence Review
24. FDA-2020-H-0646-0001Complaint
25. FDA-2011-N-0143-0391List of references re The Food and Drug Administration Food Safety Modernization Act…
26. FDA-2009-N-0376-0002Statement of Organizations, Functions, and Delegations of Authority: Office of the…
27. FDA-2021-S-0024-06452021-000980 - Renew Life - Renew Life, Optimal Energy 2-in-1 Prebiotics + Probiotics 60…
28. FDA-2011-D-0618-0039Biotechnology Industry Organization - Presentation
29. FDA-1985-G-0292-0011Attachment 7 "21 CFR 170.35 (c) (1) (i) Description of the Substance (a) Common or Usual…
30. FDA-1984-N-0259-0071Exhibit G-21.3, G-21.4, G-21.5, G-21.6 re: Disclosure of Data and Information from Center…
31. FDA-2018-H-0276-0001Complaint
32. FDA-2014-P-0585-0001Citizen Petition from A. Haggag (Capstone Law)
33. FDA-2020-E-2270-0008Letter from U.S. Patent and Trademark Office to Troutman Pepper Hamilton Sanders LLP
34. FDA-1992-S-0039-0058FDA/CVM Memo to the Division of Dockets Management Using the eSubmitter Tool Instead of…
35. FDA-2013-V-0872-0001Club Play - Application for Variance
36. FDA-2024-D-2442-0014Reference 12 - CCP guidance -Development of Monoclonal Antibody Products
37. FDA-2014-N-0189-42331Request for Extension from Sally Martin
38. FDA-2023-V-4959-0001Variance Application from Beau Burrows
39. FDA-2014-N-0189-9984Request for Extension from Anonymous
40. FDA-2023-V-2290-0001Variance Application from Michael Gerdes
41. FDA-2024-H-4103-0001Complaint
42. FDA-2025-V-0589-0002Acknowledgment Letter from FDA DMB to Phase 2 Entertainment
43. FDA-2021-P-1323-0001Citizen Petition from Lachman Consultant Services Inc on behalf of Sintetica SA
44. FDA-2025-H-0274-0001Complaint
45. FDA-2019-P-4644-0024Appendix U Ceponis et al (2008) Accurate measurement of androgen after androgen esters…
46. FDA-2023-H-4096-0001Complaint
47. FDA-2015-D-1211-0376Reference 15 MMWR_Revised Public Health Service Definition of Persons Who Should Refrain…
48. FDA-2024-P-3292-0013Suitability Petition Approval from FDA CVM to Felix Pharmaceuticals Pvt. Ltd.
49. FDA-2002-N-0098-0004Agency Information Collection Activities; Submission for OMB Review; Comment Request…
50. FDA-2015-N-0101-0575Reference 12-14 - FDA-1975-N-0012-0069 --- C8…
51. FDA-2003-N-0097-0002Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including…
52. FDA-2023-H-4881-0001Complaint
53. FDA-2025-V-0952-0002Acknowledgment Letter from FDA DMB to Sandhills Home Theater
54. FDA-2024-V-4190-0003Variance Approval Letter from FDA CDRH to Twilighting
55. FDA-2023-N-3902-1381Comment from Michael A. Partin
56. FDA-2023-H-3627-0001Complaint
57. FDA-2002-V-0348-0002The Underground Support Group - Application for Variance
58. FDA-2014-N-0189-6115Request for Extension from Anonymous
59. FDA-2024-P-4667-0275Exhibit D - Serious Adverse Events Reported to FDA for Summer’s Eve and Monistat Vaginal…
60. FDA-2012-S-1144-0361Now Foods (IGF-1) - Letter
61. FDA-2017-H-3790-0001CMP Complaint Issued to Hy-Vee, Inc. d/b/a Hy-Vee Wine and Spirits
62. FDA-2014-S-0024-0965Natural Factors Nutritional Products LTD (MultiFactors Mens Vitamin and Mineral Formula)…
63. FDA-2010-E-0049-0008U.S. Patent & Trademark Office to Goodwin Proctor - Letter
64. FDA-2023-N-3902-1409Comment from Catherine Murphy
65. FDA-1980-N-0036-0009TOPICAL ANTIFUNGAL DRUG PRODUCTS FOR OVER-THE-COUNTER - Notice of Proposed Rulemaking
66. FDA-2023-N-3902-1548Comment from Illona Santillan
67. FDA-2014-N-1051-0281280 7694105 Diary Subject R5001_Redacted
68. FDA-2003-N-0214-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Biological…
69. FDA-2002-D-0188-0001FDA
70. FDA-2016-H-3965-0001Complaint
71. FDA-2025-N-1927-0047GRAS Notice (GRN) 1164 amendments – part 2
72. FDA-1997-S-0039-1817Life Force International - Activated Charcoal - Adsorbs harmful compounds that could be…
73. FDA-2024-H-1520-0001Complaint
74. FDA-2019-E-3291-0004Letter from U.S. Patent and Trademark Office to FDA CDER
75. FDA-2025-S-0024-06132025-000704 - Procter and Gamble - Nervive Nerve Health Glucose Support - PROMOTES HEALTHY…
76. FDA-2020-S-0024-08972020-001076 Kaged Muscle - Kaged Muscle Microencapsulated Glutamine - Supports…
77. FDA-2014-N-0189-6258Request for Extension from Anonymous
78. FDA-2012-D-0530-0021Agency Information Collection Activities; Submission for Office of Management and Budge…
79. FDA-1977-N-0014-0791Answer Letter from FDA to Comment from The Honorable Doug Barnard, Jr., United States…
80. FDA-2009-S-0607-0367Perrigo - Good Neighbor Pharmacy D - Maintain Strong Bones and Teeth
81. FDA-2025-P-0341-0006Attachment 4 - FDA BE Recommendation
82. FDA-2017-H-2115-0001CMP Complaint Issued to Family Dollar Stores of Florida, LLC d/b/a Family Dollar Store…
83. FDA-2025-P-2487-0009Completeness Assessment Correspondence
84. FDA-2022-E-2204-0004Determination of Regulatory Review Period for Purposes of Patent Extension; Ukoniq
85. FDA-1982-N-0011-0065Background Material
86. FDA-2012-P-0119-0002Acknowledgement Letter to Mario Morias
87. FDA-2015-S-0024-0392Portals Pharma, Inc. - Rev•Up Wellness™ Endurance - Aids to reduce fatigue and exhaustion
88. FDA-2017-H-0655-0001CTP CMP Complaint Issued to Loussia Wine Valley, Inc. d/b/a Wine Valley Liquor
89. FDA-2023-S-0024-00682023-000072 - Fungi Perfecti LLC - Host Defense Mushrooms Cordyceps Mushroom Mycelium…
90. FDA-2004-P-0337-0003Acknowledgment Letter Correction from FDA DMB to AAC Consulting Group
91. FDA-2016-N-3818-005355 Reference 54 PRIA
92. FDA-1993-A-0385-0006Attachment 6 Cote et al Calcium chloride versus calcium gluconate: comparison of…
93. FDA-1994-P-0041-0051BACKGROUND
94. FDA-2019-N-0463-0001Addition of a New Method for the Analysis of Sulfites in Foods
95. FDA-2022-N-0766-0002Hospira, Inc., et al.; Withdrawal of Approval of 21 Abbreviated New Drug Applications…
96. FDA-2017-H-1712-0001CMP Complaint Issued to King Street Grille – Fresh Fields, LLC d/b/a King Street Grille
97. FDA-2003-N-0093-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance…
98. FDA-2019-H-0972-0001Complaint
99. FDA-2024-E-2146-0001Letter from U.S. Patent and Trademark Office to FDA CDER
100. FDA-2011-S-0932-1090FreeLife International, Inc. (TAISlim Boosters Super Greens Supplements)
101. FDA-2012-P-0119-001705 Reference 3-PDUFA _ Enhancing Benefit-Risk Assessment in Regulatory Decision-Making
102. FDA-2021-E-0106-0001Letter from U S Patent and Trademark Office
103. FDA-2009-N-0521-0002Amended Authorization of Emergency Use of the Antiviral Product Peramivir Accompanied by…
104. FDA-2010-S-0664-0440Perrigo - CareOne Daily Energy Support - Help Support Mental Alertness and Energy
105. FDA-2011-N-0793-0003Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical…
106. FDA-2013-H-1455-0001Complaint
107. FDA-2018-V-1650-0001Variance Application from Pancoast Productions Inc.
108. FDA-2016-H-0880-0002Complaint
109. FDA-2025-V-2918-0001Variance Application from Hershey Entertainment & Resorts
110. FDA-2019-P-3855-0001Citizen Petition from Latham & Watkins, LLP on behalf of Genus Lifesciences, Inc
111. FDA-2021-P-0923-0002Acknowledgment Letter from FDA DMS to Gland Pharma Limited
112. FDA-2017-P-2092-0018Interim Response Letter from CDER to Wilson Sonsini Goodrich & Rosati
113. FDA-2010-S-0664-1266Vitacost.com, Inc. - NSI Advan-C with Quercetin and Citrus Bioflavonoids
114. FDA-2009-P-0183-0006Exhibit Tab F - "Comments Regarding Prosposed Labeling, June 11 2003" - [The Procter &…
115. FDA-2011-S-0932-1307NBTY, Inc. - Children's Chewable Multivitamin Animal Shapes with Vitamin C - Children's…
116. FDA-2003-E-0259-0003U.S. Patent & Trademark Office
117. FDA-2025-S-0024-13852025-001490 - EuroPharmaTerry NaturallyEuroMedica - Terry Naturally, HRG80 Red Ginseng…
118. FDA-2015-S-0024-2730Perrigo - Kroger®-C - Vitamin C is an antioxidant that helps protect body tissue from…
119. FDA-2016-V-2487-0001Variance Request from Velodyne Lidar Inc.
120. FDA-2024-H-3493-0001Complaint
121. FDA-2008-P-0531-0001Richard F. Edlich, M.D., Ph.D. - (University of Virginia Health System) - Citizen Petition
122. FDA-1990-G-0246-0185Multigeneration Reproduction Study of Isomalt in Rats
123. FDA-2024-N-5471-0410Reference 408 - Denlinger Apte Effects of Cigarette 2019
124. FDA-2021-S-0024-13212021-1806 Source Naturals- WELLNESS D-MMUNITY- SUPPORTS OPTIMAL ABSORPTION AND UTILIZATION
125. FDA-2017-H-6210-0001Complaint
126. FDA-2017-M-5864-0001Premarket Approval Response from FDA CDRH to ZEUS Scientific, Inc. ZEUS ELISA Parvovirus…
127. FDA-2013-N-1619-0018Agency Information Collection Activities; Announcement of Office of Management and Budget…
128. FDA-1997-S-0039-1035Herbalife International of America, Inc. - LIFTOFF Lemon Cola Kick Flavor & LIFTOFF…
129. FDA-2018-H-2177-0001Complaint
130. FDA-1975-N-0248-0182Answer from FDA/OC to Honorable Robert Taft, Jr. Re: Comment Golden, Cole and Putnick
131. FDA-2007-P-0114-0006FDA/CDER Response to B. Braun Medical, Inc. - Petition Approval
132. FDA-2011-S-0932-0990New Chapter, Inc. (New Chapter Turmeric Force Supplements)
133. FDA-2017-H-5710-0001Complaint
134. FDA-2020-N-0907-0041Medical Device User Fee Amendments; Public Meeting; Request for Comments
135. FDA-2014-N-0002-0046Freedom of Information Summary ANADA 200-520 CARPRIEVE Injection carprofen Injectable…
136. FDA-2003-Q-0080-0011North American Olive Oil Association - Letter
137. FDA-2023-H-1589-0002Amended Complaint
138. FDA-2007-P-0289-0003Lachman Consultant Services, Inc. - Attachment 1 - Active Ingredient Search
139. FDA-2009-P-0326-0001Apotex Inc. - Petition for Stay of Action
140. FDA-2024-H-2946-0001Complaint
141. FDA-2018-H-0042-0001Complaint
142. FDA-2024-H-2045-0001Complaint
143. FDA-2017-H-0476-0001CMP Complaint from FDA CTP to Brian Malcolm and Stephanie Malcolm d/b/a T and S Market
144. FDA-1997-S-0039-0686Perrigo Company of South Carolina - Letter
145. FDA-2004-H-0391-0113FDA/DDM
146. FDA-1977-N-0002-1475Answer Letter from FDA to Comment from The Honorable Bob Stump, United States House of…
147. FDA-1978-N-0199-0005Request for Extension of Comment Period from Animal Health Institute
148. FDA-2024-V-2505-0002Acknowledgment Letter from FDA DMS to Miami Video Mapping LLC
149. FDA-2019-N-3065-0601Reference 6 - The Efficacy of Cigarette Warning Labels on Health Beliefs in the United…
150. FDA-2014-P-2193-0006Exhibit_D_-_Acorda_Feb__4_2011_Letter Citizen Petition From Acorda Therapeutics
151. FDA-1997-S-0039-1271Perrigo - equaline - One Daily Essential - Contains B-Vitamins necessary for the release…
152. FDA-2020-E-1257-0001Letter from U S Patent and Trademark Office
153. FDA-2024-E-5019-0001Letter from U.S. Patent and Trademark Office to FDA CDER
154. FDA-2007-M-0468-0001Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
155. FDA-2016-S-0024-1842NBTY - Iron supplements - Supports Iron-rich blood and energy utilization
156. FDA-2019-S-0023-0032NDI 1117 - Cannabidiol (CBD) from KBHEMP, LLC
157. FDA-2015-P-1296-0014Attachment 19 Regulations for In Vivo Readiopharmaceuticals Used for Diagnosis and…
158. FDA-2024-S-0024-02842024-000926 - Natrol LLC - Natrol Carb Intercept with Phase 2 - Helps delay the digestion…
159. FDA-2011-P-0115-0004Acknowledgement Letter to Cypress Pharmaceutical, Inc.
160. FDA-2024-N-5471-0598Reference 596 Rostron Cigar smoking prevalence and morbidity 2019
161. FDA-2023-P-0219-0005Attachment 3 - Endnotes 44-49_51_53-55_62-64_66_69-72_74-78_86 re Citizen Petition from…
162. FDA-2011-N-0003-0018Freedom Of Information Summary - [NADA 141-322]
163. FDA-1997-S-0039-0196[LET75] - Nature's Herbs (Siberian Ginseng Power) - Letter
164. FDA-2003-P-0272-0009Memorandum of Telephone Conversation Between FDA/CFSAN and Compassion Over Killing, Inc…
165. FDA-2008-V-0436-0006FDA/CDRH Response to Streamlight Inc. - Approval of Variance
166. FDA-2016-E-2525-0003Letter from FDA CDER to the U.S. Patent and Trademark Office
167. FDA-2020-P-1423-0004Appendix 2 Codex Standard re Citizen Petition from North American Olive Oil Association
168. FDA-2014-P-0585-0002Acknowledgement letter from FDA DDM to Capstone Law APC
169. FDA-2016-S-0024-2061Now Health Group Inc - NOW® Soy-Free Phosphatidyl Serine - Phosphatidyl Serine plays an…
170. FDA-2021-S-0024-10502021-001356 - Natural Immunogenics Corp - Sovereign Copper, Bio-Active Copper Hydrosol…
171. FDA-2011-N-0922-0541REFERENCE LIST for Final Regulatory Impact Analysis (FRIA) re Current Good Manufacturing…
172. FDA-2014-E-0072-0003Letter from FDA CDER to U.S. Patent and Trademark Office
173. FDA-2022-D-0986-0008Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations—…
174. FDA-1987-N-0010-0144Background Material
175. FDA-1993-G-0218-0008Letter from FDA/CFSAN to Phoenix Regulatory Associates, Ltd.
176. FDA-2003-N-0257-0003Hoestenbach, Roger
177. FDA-1997-S-0006-0478HFS-456 to 4 Health Inc - Letter - Let 187
178. FDA-2003-N-0257-0044Introduction to April 5, 2005 meeting
179. FDA-2018-V-0246-0003Approval Letter from FDA CDRH to MARZ MEDIA INC
180. FDA-2017-H-5566-0001Complaint
181. FDA-2022-H-0473-0001Complaint
182. FDA-2010-N-0295-0006Reference 2 - "National Cancer Institute, U.S. Department of Health & Human Services, The…
183. FDA-2002-N-0265-0053Hogan & Hartson LLP - Electronic Request for Appearance
184. FDA-2024-H-0624-0001Complaint
185. FDA-2013-H-1117-0001Complaint
186. FDA-2025-H-3359-0001Complaint
187. FDA-2019-H-5168-0001Complaint
188. FDA-2006-N-0239-0012Request to Extend Comment Period from American Veterinary Medical Association (AVMA)
189. FDA-2022-N-0082-0001Vaccines and Related Biological Products Advisory Committee; Notice of Meeting…
190. FDA-2017-H-3599-0001CMP Complaint Issued to Food Lion, LLC d/b/a Food Lion 336
191. FDA-2016-N-3120-05170007_m5_study r10-0828_case report forms
192. FDA-2019-H-1696-0001Complaint
193. FDA-2009-S-0607-0325Market America, Inc. - Isotonix Vitamin D with K12 & Isotonix l-Tryptophan & Might-A-Mins…
194. FDA-2019-H-1669-0001Complaint
195. FDA-2017-P-4372-0001Attachment 1- Biosmetics Eye Care re Citizen Petition from AEGIS Regulatory, Inc.
196. FDA-2019-V-2928-0001Variance Application from Sean Vogt
197. FDA-2020-H-0125-0001Complaint
198. FDA-2024-E-4131-0004Letter from U.S. Patent and Trademark Office to FDA CDER
199. FDA-1997-S-0006-0304HFS-451 to Leiner Health Products - Letter - Let 14
200. FDA-2024-H-2436-0001Complaint
201. FDA-2022-E-0655-0003Letter from FDA CDER to U.S. Patent and Trademark Office
202. FDA-2025-P-3510-0006Attachment 4 - ANDA 090384 Approval Letter Docket No. FDA-2012-P-1259, FDA-2011-P-0052
203. FDA-2014-D-0310-0008Guidance for Industry; Immunogenicity-Related Considerations for Low Molecular Weight…
204. FDA-2004-E-0266-0003NPS Pharmaceticals Inc. and Brigham and Women's Hospital - Patent Term Extension…
205. FDA-2021-V-0580-0002Acknowledgment Letter from FDA DMS to Overland Meat Co
206. FDA-2018-H-4884-0001Complaint
207. FDA-1978-N-1682-0041Withdrawal of Certain Pre-1986 Proposed Rules; Final Action
208. FDA-2023-N-3902-0564Comment from Tanya Steele
209. FDA-2003-E-0110-0009USPTO to Pfizer Inc. - Order to Show Cause - Letter
210. FDA-2020-V-1537-0003Acknowledgment Letter from FDA DMS to Frank Lopez
211. FDA-1977-N-0002-0862Envelope re: Comment from Honorable Ernest F. Hollings, United States Senate
212. FDA-1990-N-0172-0090Request to Extend Comment Period from Pharmacaps, Inc
213. FDA-2007-N-0156-0002FDA
214. FDA-2020-V-2321-0003Variance Approval Letter from FDA CDRH to Zachary Taylor
215. FDA-1982-N-0011-0027Background Material
216. FDA-2025-H-7404-0001Complaint
217. FDA-2013-E-0411-0001Astellas Pharma Inc. (Fitzpatrick, Cella, Harper & Scinto) - Patent Extension Application
218. FDA-2003-N-0248-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious…
219. FDA-2021-N-0648-0001Medical Devices; Orthopedic Devices; Classification of the Intraoperative Orthopedic…
220. FDA-1978-N-0018-0583Envelope re: Comment from Dr. John M. O'Bannon, III, Commonwealth of Virginia House of…
221. FDA-2012-S-1144-0419NOW - NOW® Methyl B-12 Lozenges - Nervous System Health
222. FDA-2023-D-3132-0002Implementation Evidentiary Expectations for510(k) Implant Devices; Draft Guidance for…
223. FDA-2013-N-0883-0002FDA/DDM Notification to Purdue Pharma L.P. - Letter
224. FDA-2014-N-0189-6491Request for Extension from Anonymous
225. FDA-1980-N-0038-0059Letter from Syntex Laboratories, Inc. to J. Richard Crout
226. FDA-2021-S-0024-07592021-001113 - Bonafide Health LLC-Clairvee- maintains a healthy vaginal pH
227. FDA-2018-V-1381-0003Variance Approval Letter from FDA CDRH to Graveyard Tracks LLC
228. FDA-2016-D-0545-0009Reference 6 - Genetic Characterization of Zika Virus Strains - Recommendations for Donor…
229. FDA-1977-N-0014-1094Answer Letter from FDA/Office of Legislative Services to Honorable James L. Oberstar…
230. FDA-2017-P-5787-0053Reference 51 Gao_Chemistry and Structural Biology of AR (Chem Rev 2005) re Citizen…
231. FDA-2019-H-2045-0001Complaint
232. FDA-2024-N-3382-0001Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and…
233. FDA-2008-N-0039-0021Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Solution
234. FDA-2004-P-0017-0001Acknowledgement Letter from FDA CDER to Pharmacists Planning Service, Inc. (PPSI)
235. FDA-2006-E-0319-0002HFD-5 to U.S. Patent and Trademark Office
236. FDA-2017-H-2442-0001CMP Complaint Issued to Earl L. Pickett Enterprises, Inc. d/b/a Town N Country
237. FDA-2019-D-1469-0001M10 Bioanalytical Method Validation; International Council for Harmonisation; Draft…
238. FDA-2018-D-2173-002926 Reference 26 Guidance Early-Phase Clinical Trials of CGT products - UCM359073
239. FDA-1980-N-0038-0203Vioform Hydrocortisone Hearing (Vol 16 of 34)
240. FDA-2007-P-0107-0002See FDA-2007-P-0107-0001
241. FDA-2024-H-4543-0001Complaint
242. FDA-2018-V-0198-0003Variance Approval Letter from FDA CDRH to DOWNATA HOT SPRINGS
243. FDA-2008-P-0647-0002Acknowledgement Letter to Lachman Consultant Services, Inc.
244. FDA-1997-S-0039-1705Letter from New Chapter, Inc.
245. FDA-2010-D-0370-0009Reference 6 - "Overweight and Obesity Internet Webpage: “Health Consequences,” Centers for…
246. FDA-2018-N-4626-0714Nomination from Wedgewood Pharmacy
247. FDA-2009-S-0607-0912Perrigo - CareOne Potassium - Proper Nerve and Muscle Function
248. FDA-2019-P-1525-0001Citizen Petition from Baxter Healthcare Corporation
249. FDA-2009-N-0392-1305Robert E. Byron - Letter
250. FDA-1997-S-0039-0523Source Naturals - Taurine 1000 - It is a soothing neurotransmitter and plays a major role…
251. FDA-2018-H-4366-0001Complaint
252. FDA-2014-N-0053-1308Reference 24 - FDA Memorandum - Categorical Exclusion--Requirements for Additional…
253. FDA-2012-S-1144-0311NBTY, Inc. - Triple Omega 3-6-9 - Supports Heart Health
254. FDA-2017-H-4108-0001CMP Complaint Issued to Burhans Market, Inc. d/b/a Byers Stop N’ Go / Byers Dairy King
255. FDA-1995-N-0063-0143Reference 55 Southgate et al Nutrient Availability: Chemical and Biological Aspects
256. FDA-2014-N-0189-42659Request for Extension from Joshua Gearheart, Aces Vapor, LLC
257. FDA-2015-H-4886-0001CTP CMP Case re Keg Investments, LLC d/b/a Bedroom Goldmine Bar
258. FDA-2025-H-3769-0001Complaint
259. FDA-2009-S-0608-0086NDI 586 - Oxaloacetic Acid - Original NDI Notification
260. FDA-2019-D-3764-0002Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products or Type A…
261. FDA-2023-H-2023-0001Complaint
262. FDA-2011-S-0932-0731NBTY, Inc. (Naturalist Label Cinnamon Supplements)
263. FDA-1997-S-0039-0493[LET3250] Natural Balance Inc., (Super Pep) - Letter
264. FDA-2017-S-0024-0197Nordic Naturals - Multiple Claims (4) - Omega Curcumin - support cells in the body, Redu…
265. FDA-2005-P-0003-0008Sandoz Inc. - Supplement
266. FDA-2017-D-5138-0013S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals…
267. FDA-1995-V-0012-0001Laseronics Northwest - Approval for Variance
268. FDA-2011-S-0932-1396Perrigo Company of South Carolina - TopCare®- Vitamin D - Bone Health
269. FDA-2020-N-2029-03322022-08-23 CDERs Follow-up Questions Regarding Covis Response to CDERs Objections RE…
270. FDA-2015-S-0024-1020USANA Health Sciences - Mega Antioxidant - Mega Antioxidant supplies precisely balanced…
271. FDA-2006-P-0391-0003Letter from FDA CDER to Orchid Healthcare
272. FDA-2019-V-2214-0002Acknowledgement Letter from FDA DDM to Laser Lake, LLC
273. FDA-2018-V-3779-0001Variance Application for Pink Palace Family of Museums
274. FDA-1978-N-0368-0002Medical Devices Classification of Hematology Stains
275. FDA-2016-H-2022-0001Complaint
276. FDA-2013-S-0024-0637SOLSTICE MEDICINE COMPANY - Yang Xue Sheng Fa Capsules Herbal Supplement - Supports the…
277. FDA-2019-V-5708-0001Variance Application from JPC Entertainment, LLC
278. FDA-2016-D-2335-1630Reference 13. Health Claim Notification for the Substitution of Saturated Fat in the Diet…
279. FDA-2025-S-0024-06052025-000696 - Basic Research LLC - Zantrex Black - GLP-1 Support
280. FDA-2017-H-0678-0001CMP Complaint from FDA CTP to MG Energy LLC d/b/a Puma San Patricio
281. FDA-2011-D-0091-0001Draft Guidance for Industry; Availability: Testing for Salmonella Species in Human Foods…
282. FDA-2012-V-1157-0002Acknowledgement Letter to Sweet Sensations
283. FDA-2006-P-0270-0010Xanodyne Pharmaceuticals, Inc. Letter to FDA - Supplement Comment
284. FDA-2021-V-0143-0002Acknowledgment Letter from FDA DMS to Dallas Sight and Sound Inc
285. FDA-2023-N-3743-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic…
286. FDA-2003-N-0446-0007BACKGROUND
287. FDA-2016-P-2782-0005Exhibit 3 re Request the Commissioner of FDA to require any ANDA applicant who cites…
288. FDA-2025-V-0607-0001Variance Application from Michael Mohan
289. FDA-2010-S-0664-0600EuroPharma, Inc. - Recovery I - Sustained Energy and Stamina
290. FDA-1999-D-0064-0006Guidance for Industry Impurities in New Veterinary Drug Substances (Revision) VICH GL10(R)…
291. FDA-2022-H-2721-0001Complaint
292. FDA-1994-P-0041-0217BACKGROUND
293. FDA-2011-N-0492-0001Agency Information Collection Activities; Proposals, Submissions, and Approvals: Class II…
294. FDA-1997-S-0006-1176Zarbee's Inc (All-Natural Aller-Defense) LET1174 Response From FDA/CFSAN - Courtesy Letter
295. FDA-1979-N-0029-0004Exocrine Pancreatic Insufficiency Drug Products for Over-the-Counter Human Use; Tentative…
296. FDA-2019-H-4175-0001Complaint
297. FDA-2020-D-0957-0144144-Guidance-on-the-Department-of-Defense-Exemption-from-the-FDA-Performance-Standard-for…
298. FDA-2012-F-0480-0007Index of References re Food Additives Permitted for Direct Addition to Food for Human…
299. FDA-2015-D-2818-0002Draft Guidance for Rare Diseases: Common Issues in Drug Development Guidance for Industry
300. FDA-1980-N-0038-0139Certain Topical Anti-Infective Drug Products; Vioform-Hydrocortisone (Iodochlorhydroxyquin…
301. FDA-2007-P-0176-0003Lachman Consultant Services, Inc. - Citizen Petition
302. FDA-2025-V-0395-0001Variance Application from Valo Productions Indy
303. FDA-2001-P-0565-0003Attachment 2
304. FDA-2015-S-0024-2550Nutrition Express - Lindberg® Pink Pack Multi-Vitamin & Mineral Packets - Healthy Support…
305. FDA-2019-E-2092-0005Determination of Regulatory Review Period for Purposes of Patent Extension; POTELIGEO
306. FDA-2017-H-0816-0001CMP Complaint Issued to Industrial Park Party Store, Inc. d/b/a Industrial Park Party…
307. FDA-2009-S-0607-0818Perrigo - CareOne Super Multi - Promote Healthy Eyes
308. FDA-2012-N-0882-0001Generic Drug User Fee Amendments of 2012 Meeting
309. FDA-2020-N-0008-0004Advisory Committee; Vaccines and Related Biological Products Advisory Committee; Renewal
310. FDA-2020-N-0025-0054INTERAGENCY WORKING GROUP ON ASBESTOS IN CONSUMER PRODUCTS (IWGACP); Appendices to White…
311. FDA-1998-E-0820-0001Colgate Palmolive Co - Patent Term Extension Application
312. FDA-1994-P-0028-0021Exhibit 1: Letter from FDA CDER re Correction from Geneva Pharmaceuticals, Inc. (Mckenna &…
313. FDA-2018-N-3263-0004Request for Nominations for Voting Members on a Public Advisory Committee; the Tobacco…
314. FDA-1995-S-0036-0156Hennepin County Medical Center Emergency Medicine Department pre IND 122444 re Ketamine…
315. FDA-2009-N-0184-0031Attachment 20 - "Effects of Omeprazole on the Pharmacokinetic Profiles of Lisdexamfetamine…
316. FDA-2011-M-0563-0002Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications…
317. FDA-2004-P-0209-0002Acknowledgment Letter from FDA DMB to Intervet, Inc.
318. FDA-2016-H-1929-0001Complaint
319. FDA-1997-G-0376-0078Reference 146 - Environmental Assessment - Appendix 7/6 - Acute Toxicity Study on…
320. FDA-2011-S-0932-2123NBTY, Inc. - L-Lysine supplements - Immune Health
321. FDA-2018-H-3911-0001Complaint
322. FDA-1995-N-0054-13531Background Material for NFR 1
323. FDA-2023-N-3902-0892Comment from United Cerebral Palsy (UCP)
324. FDA-2024-H-2782-0001Complaint
325. FDA-1978-N-0622-0001Classification of Calibrators for Red Cell and White Cell Counting
326. FDA-2012-D-0524-0002Draft Guidance for Industry and Food and Drug Administration Staff: Acceptance and Filing…
327. FDA-1997-S-0006-1158Phoenix Global Supply Group LET1158 Response From FDA/CFSAN - Courtesy Letter
328. FDA-2022-H-1964-0001Complaint
329. FDA-1980-N-0038-0290Supplement from Center for Drugs and Biologics (CDB) (Vol. 10 of 15)
330. FDA-2020-S-0024-15012020-001421 NOW Foods- Lucky Vitamin, Apple Pectin- Supports Intestinal Health
331. FDA-2017-H-3297-0001CMP Complaint Issued to Pay-Less Markets, Inc. d/b/a Pay-Less Supermarkets
332. FDA-2013-E-1690-0002CEPHALON, Inc. - Patent Term Application
333. FDA-1978-N-0018-0195FDA
334. FDA-1998-N-0068-0005HFM-17
335. FDA-2022-P-0110-0001Citizen Petition from Center for Science in the Public Interest
336. FDA-2017-S-0024-0134Innovative Science Solutions on behalft of American Lifeline, Inc. - 3, Florajen4Kids®…
337. FDA-2016-H-0239-0001CTP CMP Case re Mei Hong Du d/b/a Golden Restaurant
338. FDA-2012-N-0280-0010Agency Information Collection Activities; Proposed Collection; Comment Request; Financial…
339. FDA-1985-P-0501-0008Acknowledgement Letter from FDA/DDM to Burditt, Bowles & Radzius, Chartered
340. FDA-2016-S-0024-0979NOW Health Group, Inc - Liquid Betaine - Enhances Exercise Performance
341. FDA-2016-N-3120-0085111_FDA Study Subject_Redacted
342. FDA-2024-H-4282-0001Complaint
343. FDA-2011-V-0616-0001Excalibur International - Application for Variance
344. FDA-2013-P-0944-0002Acknowledgement Letter to Jeffrey G. Thomas DBA Thomas Law Company
345. FDA-2004-N-0511-0022Attachment 1 Copy of Federal Register 70FR218 Obstetrical and Gynecological Devices…
346. FDA-2023-N-3902-0872Comment from Martha Barletta
347. FDA-1977-N-0014-1190Answer from FDA to Comment from Honorable Hubert H. Humphrey United States Senate
348. FDA-2023-N-3392-0020Reference 18 - CDC, Antibiotic Resistance Threats in the United States 2019 Report
349. FDA-2020-S-0024-1075SFC2020-001262 Pharmavite LLC - Nature Made Collagen Gummies with C and Zinc - Supports…
350. FDA-2019-H-3970-0001Complaint
351. FDA-2022-S-0024-14542022-002022 - Santa Cruz Nutritionals - Walgreens Adult Biotin Gummies 10,000mcg 90ct…
352. FDA-2017-S-0024-04642017-5670 VieSun Inc. - Gandalf Spirulina 100% Vegan Organic Spirulina powder - Supports…
353. FDA-2015-S-0024-2845Health Genesis Corporation - BioGenuine Zinc Picolinate 50 mg 60 capsules - Helps support…
354. FDA-2006-P-0458-0001Acknowledgment Letter from FDA DMB to Lupin Pharmaceuticals, Inc.
355. FDA-2005-P-0318-0006Attachment A Approved Drug Products with Therapeutic Equivalence Evaluations 24th ed re…
356. FDA-2018-P-1593-0016Egg Nutrition Center_Nutrients in Eggs 2018 re Citizen Petition from Pete and Gerry’s…
357. FDA-1984-N-0259-0280Protective Order with Respect to Documents Relating to the Safety and Efficacy of Drug…
358. FDA-2024-H-0960-0001Complaint
359. FDA-1997-S-0039-2602NBTY, Inc. - Mega Vita Women Supplements- Multivitamin- Heart Health
360. FDA-2007-D-0369-2418PSG_214938 - Draft Guidance on Vosoritide
361. FDA-2024-H-1007-0001Complaint
362. FDA-2017-H-5254-0001Complaint
363. FDA-2009-S-0607-1514Roex, Inc. - K2+ Supercharged Complex - Promotes Blood Health
364. FDA-2016-P-2515-0027Petition Denial Letter
365. FDA-2011-S-0932-1721Vitacost.com , Inc., d/b/a Nutraceutical Sciences Institute - NSI® Liquid Mega EFA Omega-3…
366. FDA-2004-P-0283-0001Acknowledgment Letter from FDA DMB to Lachman Consultant Services, Inc.
367. FDA-2017-S-0024-07262017000880 - Vitacost.com, Inc - Vitacost Synergy Super EPA Omega-3 -- 1200 mg per serving…
368. FDA-2015-N-1305-0006Request for Extension from International Dairy Foods Association (IDFA)
369. FDA-2019-H-3285-0001Complaint
370. FDA-2020-P-2304-0003Attachment A – Orange Book Listing of Sodium Chloride 14.6% - NDA 018897 RE Citizens…
371. FDA-2021-N-1309-0303Reference 300 HHS The Health Benefits of Smoking Cessation 1990
372. FDA-2006-V-0465-0002FDA /DDM to Griffith Observatory, (Oschin Planetarium)
373. FDA-2013-D-0715-0002Draft Guidance for Industry on Acrylamide in Foods
374. FDA-2019-H-3584-0001Complaint
375. FDA-1998-N-1169-0002Reference 4 re Cost-effectiveness of expanded human immunodeficiency virus-testing…
376. FDA-2019-H-2331-0001Complaint
377. FDA-1978-N-0011-0055Citizen Petition Denial Response Letter From FDA/ORA To The Cosmetic, Toiletry, And…
378. FDA-1997-S-0039-1532Perrigo Company of South Carolina-Glucosamine & Chondroitin
379. FDA-2025-H-3253-0001Complaint
380. FDA-2005-P-0253-0010J. Shuren, Assistant Commissioner for Policy
381. FDA-2025-R-5787-0001Complaint
382. FDA-1993-G-0218-0476Part A: Section 6: Revised Environmental Assessment - Oat Fiber
383. FDA-2021-V-1066-0009Variance Approval from FDA CDRH to JEDEYEPRODUCTIONS LLC.
384. FDA-2016-E-2267-0002Patent Extension Application from Honigman Miller Schwatrz & Cohn LLP (on behalf of…
385. FDA-2020-H-0319-0001Complaint
386. FDA-2011-N-0146-0116Record of Outreach Sessions from FDA/CFSAN
387. FDA-2014-N-0189-7253Request for Extension from Anonymous
388. FDA-2019-H-0437-0001Complaint
389. FDA-2013-P-1612-0096Letter from FDA/CDER to David B. Shirley, D. V. M.
390. FDA-2018-H-0436-0001Complaint
391. FDA-2022-H-1174-0001Complaint
392. FDA-2012-S-1144-1745Natural Organics Inc - Complete Body Cleanse - Nutritional support for healthy elimination
393. FDA-1999-P-0157-0001FDA/CVM Email to DDM
394. FDA-2003-P-0126-0001Acknowledgment Letter from FDA DMB to HRA PHARMA
395. FDA-2020-H-0887-0001Complaint
396. FDA-1989-N-0408-0006General Biological Products Standards; Test for Residual Moisture
397. FDA-2017-S-0024-06222017000770 - Dymatize Enterprises, LLC - Dymatize BCAAs (Unflavored, Blue Raspberry…
398. FDA-2013-D-1170-0009Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for…
399. FDA-2015-S-0024-3148Perrigo - Meijer™ - promotional - The body needs beneficial bacteria for digestive system…
400. FDA-2012-D-0097-0039Providing Regulatory Submissions In Electronic Format —Standardized Study Data; Guidance…
401. FDA-2010-P-0393-0002Attachment 1 - Cited News Articles, PharmaExec.com, Scrip News, BMI Industry Insights..."…
402. FDA-2023-V-1976-0002Acknowledgment Letter from FDA DMS to Knight High School
403. FDA-2021-S-0024-01592021-000164 Ascendant Beauty - JLO BEAUTY THAT INNER LOVE DIETARY SUPPLEMENT - helps fight…
404. FDA-2025-P-0415-0004Memorandum to File Administrative Closure of Docket
405. FDA-1997-S-0039-2606Perrigo Company of South Carolina - Target™ - women's daily multivitamin - Ingredients to…
406. FDA-2010-S-0664-0487Perrigo - CareOne Glucosamine Chondroitin Complex-MSM - Help with Knee Comfort
407. FDA-1976-P-0030-0001Revision of Procedures Relating to Category III - Notice of Final Rule
408. FDA-2018-V-0195-0001Variance Application from Acoustic-Optics
409. FDA-2017-H-3931-0001CMP Complaint Issued to Tradewind Shell, LLC d/b/a Shell
410. FDA-2024-V-4518-0001Variance Application from David Donaldson
411. FDA-2000-N-0190-0038Reference 26 - "Table 20 Poultry-Inventory and Sales: 1997 and 1992" - [Prevention of…
412. FDA-1997-S-0039-2433Perrigo - equaline - One Daily Women's - Promotes Healthy Skin with Vitamin A, Vitamin C…
413. FDA-2011-S-0933-0050Reference 2- Redacted in its Entirety (8 Pages) re NDI 683, TA-65: Cycloastragenol, a…
414. FDA-2014-H-2311-0001Complaint
415. FDA-2023-N-3902-0278Comment from Hrysoula Lazaropoulos
416. FDA-2015-N-0101-1014Reference 106 - FDA Guidance Nonclinical Safey Evaluation of Pediatric Drug Products re…
417. FDA-2021-V-0837-0001Variance Application from Len Ricci
418. FDA-2000-N-0112-0135Q2 Marketing Research Inc. - Testimony
419. FDA-2022-D-0467-000704 CDC HIV Surveillance Report 2022
420. FDA-2015-S-0024-1203NBTY - Women's Daily Formula supplements - This formula contains essential nutrients for…
421. FDA-2023-N-3902-1371Comment from Anely Herrera
422. FDA-2022-H-2592-0001Complaint
423. FDA-2025-S-0024-00342025-000078 - Affirm Health - Proceive Max Men- Tailored Fertility Complex
424. FDA-2017-S-0024-0192FoodScience Corporation - Andro Benefits (Da Vinci Laboratories) - Supports Hormone…
425. FDA-1997-S-0039-2034Perrigo Company of South Carolina - Equaline® - Glucosamine Chondroitin - Helps Rebuild…
426. FDA-2019-H-1104-0001Complaint
427. FDA-2019-H-4732-0001Complaint
428. FDA-2014-V-1358-0001Variance Application from Stage Directions
429. FDA-2011-S-0932-0130Letter from NBTY, Inc.
430. FDA-2014-P-1065-0004Acknowledgement Letter From FDA DDM to Zydus Oharmaceuticals
431. FDA-1999-H-0018-0002FDA/CDRH/GCF
432. FDA-2025-E-0158-0001Letter from U.S. Patent and Trademark Office to FDA CDER
433. FDA-2015-S-0024-0067NBTY Inc - Osteo Bi-Fiex Ease supplements - Joint Health
434. FDA-1984-N-0259-0427Proposed Corrections to Transcript from Mead Johnson and Company (Kleinfeld, Kaplan and…
435. FDA-2008-P-0242-0043Tab 4 - National Toxic Encephalopathy Foundation - Photo of Angel Parfum Box[Back]…
436. FDA-2009-E-0073-0009Morgan, Lewis & Bockius LLP (Eli Lilly and Company) - Letter
437. FDA-2023-N-3902-0987Comment from Janice Gardner
438. FDA-1994-F-0156-0004Rhone-Poulenc Animal Nutrition Errata
439. FDA-2015-N-3469-0125Nomination from Outsourcing Facilities Association
440. FDA-1978-N-0018-06902009 Market Analysis - Study Report - Report
441. FDA-2016-H-0836-0001CTP CMP Case re Assume 1st Incorporated d/b/a BP
442. FDA-2018-D-2478-0029Reference 26 Menis et al Emerg Infect Dis 2012 re: Recommendations for Reducing the Risk…
443. FDA-2017-P-4409-0002Acknowledgement Letter from FDA DDM to Hyman, Phelps & McNamara, PC
444. FDA-1984-G-0019-0067Letter from Ad Hoc Enzyme Technical Committee to FDA
445. FDA-2021-D-0872-0002Electronic Submission Template for Medical Device 510(k) Submissions; Draft Guidance for…
446. FDA-2024-V-1300-0001Variance Application from Brent Meier
447. FDA-2015-S-0024-2358NBTY, Inc. - Vitamin D3 - Supports bone and immune health
448. FDA-2023-N-4225-0047PRIA Footnote Reference 2 Circular A-4
449. FDA-2016-H-1972-0001Complaint
450. FDA-2017-S-0024-0023Jackson Walker LLP on behalf of Natural Aloe de Costa Rica 5, Naturmanan ACE+, Helps…
451. FDA-2020-H-0852-0001Complaint
452. FDA-2017-P-2365-0002Acknowledgement Letter from FDA DDM to Senators Schumer & Gillibrand
453. FDA-2014-N-0189-57953Request for Extension from Anonymous
454. FDA-2014-D-0055-0590Reference 27 - *Aburto NJ, Ziolkovska A, Hooper L, Elliott P, Cappuccio FP, Meerpohl JJ…
455. FDA-2022-P-2425-0037Reference 34 - Sellers F, Nirappil F. Confusion post-Roe spurs delays, denials for some…
456. FDA-2025-H-3921-0001Complaint
457. FDA-1982-N-0005-0089Final Report: Comparison of Emetrol Versus Placebo In Treating Upset Stomach In Children…
458. FDA-2012-S-1144-1260Now Foods - Odor Controlled Garlic - Garlic abounds with naturally occurring sulfur…
459. FDA-2023-N-3902-0424Comment from Joe Lippeatt
460. FDA-2025-S-0024-13722025-001477 - Vimergy LLC - Vimergy, Total Immune Blend - Total Immune Blend
461. FDA-2023-H-4215-0001Complaint
462. FDA-2024-H-0413-0001Complaint
463. FDA-2024-H-3309-0001Complaint
464. FDA-2021-P-0677-0005Attachment 3 (Diltiazem HCl ER Capsules ANDA SP) Diltiazem Hydrochloride Extended-Release…
465. FDA-1978-N-0018-0502Exhibit A: Final Order, Opinion, etc. In Regard to Violation of Sec.5 of the Federal Trade…
466. FDA-2022-H-3003-0001Complaint
467. FDA-2020-V-2009-0002Acknowledgment Letter from FDA DMS to Josh Altum
468. FDA-2015-H-0976-0001Complaint
469. FDA-2022-S-0023-0026NDI 1245 - W Beauty® Wasabi Leaf Extract - Original NDI Notification
470. FDA-2016-H-1937-0001Complaint
471. FDA-2021-S-0023-0074NDI 1216 - Emacrit - Original NDI Notification
472. FDA-2021-S-0024-14512021-001574 - Madison One Acme Inc- Great Wall Brand, Yin Chiao Chieh Tu Pien- supports…
473. FDA-2017-H-1735-0001CMP Complaint Issued to 7-Eleven, Inc. d/b/a 7-Eleven
474. FDA-1978-N-0018-0771Letter from The Proprietary Association to FDA
475. FDA-1994-P-0013-0002Letter from FDA CFSAN to Minnesota Cultivated Wild Rice Council- Envelope
476. FDA-2008-N-0312-0007Agency Information Collection Activities; Submission for Office of Management and Budget…
477. FDA-2022-E-2013-0001Letter from U S Patent and Trademark Office
478. FDA-2022-S-0024-06372022-000665 - Lang Pharma Nutrition Inc. - CVS Health Complete Prenatal Minis - Supports…
479. FDA-2008-E-0103-0008Notice of Final Determination and Requirement for Election - U.S. Patent and Trademark…
480. FDA-2011-D-0611-0054Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price…
481. FDA-2004-N-0506-0003Supporting Statement - Specific Requirements on Content and Format of Labeling for Human…
482. FDA-2023-N-3902-0477Comment from Jessica Morrow
483. FDA-2021-P-0267-0009Reference 7 - Designed for Deception: The fail-safe way to ensure that their studies would…
484. FDA-2012-S-1144-2235Perrigo - CareOne - Coenzyme Q-10 - Helps support healthy heart function
485. FDA-2016-P-1246-0007Response Letter from FDA CDER to the Working Group on Women's Health and Well-Being in…
486. FDA-2019-N-5969-0002John Seil Lee: Final Debarment Order
487. FDA-2002-N-0462-0008Testimony from Jon Clark
488. FDA-2022-S-0024-08212022-000863 - i-Health Inc.- Culturelle Baby Immune + Digestive Support- support digestive…
489. FDA-2024-H-1971-0001Complaint
490. FDA-2010-P-0430-0004Attachment 3 - "FDA Response to Andrx Pharmaceuticals, Inc., Shared Exclusivity for…
491. FDA-1992-P-0066-0006Letter from Sidley & Austin, on behalf of N2 Products Corporation to FDA CDER
492. FDA-1995-V-0012-0017FDA/CDRH to Laseronics Northwest - Approval for Variance
493. FDA-2024-N-5471-0075Reference 73 - Hughes Effects of abstinence from tobacco 2007
494. FDA-2011-S-0932-2932Miracle Breakthrough Lab Inc - Advanced Resveratrol Mega Plus - Helpful in maximizing your…
495. FDA-2024-P-3090-0011Response Letter from FDA CDER to Epic Pharma, LLC
496. FDA-2015-S-0024-2772Perrigo Company of South Carolina - Target up & up® - Calcium Citrate + D3 - Bone Health
497. FDA-2018-N-3684-0001Medical Devices; Anesthesiology Devices; Classification of the Positive Airway Pressure…
498. FDA-2017-H-5233-0001Complaint
499. FDA-2020-H-0084-0001Complaint
500. FDA-2024-V-0947-0003Variance Approval Letter from FDA CDRH to Vai Resort LLC
501. FDA-2019-H-0280-0001Complaint
502. FDA-2015-S-0024-0444USANA Heath Sciences, Inc. - BiOmega Jr. - A delicious burst of omega-3s to support…
503. FDA-2016-V-1089-0001Variance Application from Data Wordserve Inc
504. FDA-1990-S-0006-0062Statistical Report - Month of January 2004
505. FDA-2007-S-0484-0031NDI 385 - Sodium Hydroxide and Potassium Hydroxide form PHX Health Solutions, Inc.
506. FDA-2012-S-1144-1425NBTY, Inc. - Iron - Helps Maintain Energy Utilization & Promote Red Blood Cell Production
507. FDA-1998-N-0051-0006Application for Exemption from Program Support Center, DHHS
508. FDA-1996-N-0270-0560CVM GFI #67 Small Entities Compliance Guide for Renderers
509. FDA-2017-H-6459-0001Complaint
510. FDA-2016-E-2063-0004Acknowledgment of Express Withdrawal of Application for Extension of Patent Term from U.S…
511. FDA-2001-P-0194-0001FDA/DDM to Dade Behring Inc.
512. FDA-2013-D-1181-0003Guidance for Industry; Acute Bacterial Skin and Skin Structure Infections: Developing…
513. FDA-2015-P-0720-0004Attach II Citizen Petition from ZYDUS Pharmaceuticals Inc
514. FDA-2011-S-0932-0566Letter from NBTY, Inc.
515. FDA-2016-N-0544-0003Reference 2 PhRMA Guiding Principles Direct to Consumer Advertisements About Prescription…
516. FDA-2022-E-0656-0004Determination of Regulatory Review Period for Purposes of Patent Extension; Amondys 45
517. FDA-2013-V-0223-0003FDA/CDRH to Brents Music Headquarters - Approval for Variance
518. FDA-1976-N-0517-0006FDA
519. FDA-2023-N-3902-0700Comment from Lawrence Frey
520. FDA-2014-N-1533-0022Agency Information Collection Activities; Submission for Office of Management and Budget…
521. FDA-2017-P-6219-0003Attachment 1 FDA Orange Book page for Exalgo® (Hydromorphone HCl), extended-release…
522. FDA-2013-P-1058-0002Acknowledgement Letter to IntelGenx Corporation
523. FDA-1987-N-0010-0283Background Material
524. FDA-2017-H-0937-0001CMP Complaint Issued to JR Pub LLC d/b/a JR’s Pub
525. FDA-2013-S-0024-0206Platinum Performace, Inc. (Platinum Immune Support) - Letter
526. FDA-2013-P-1641-0006Supplement from Teva Pharmaceutical Industries Ltd.
527. FDA-2014-N-1051-0160158 7694105 diary subject r3032_Redacted
528. FDA-2019-H-1354-0001Complaint
529. FDA-2016-H-0917-0001CTP CMP Case re Wine King LLC d/b/a Wine Outlet
530. FDA-2025-S-0023-0043NDI 1391 - Fisetin (Cotinus Coggygria) - Original NDI Notification
531. FDA-2016-E-0626-0002Letter from U.S. Patent and Trademark Office
532. FDA-1997-S-0006-1522Courtesy Letter from CFSAN to GAD Industries
533. FDA-2021-S-0024-06692021-000986 - Renew Life - Renew Life, Kids Daily Complete Probiotics + Organic Prebiotics…
534. FDA-2024-H-4537-0001Complaint
535. FDA-2020-D-1136-0010Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing…
536. FDA-2017-H-0466-0001CMP Complaint from FDA CTP to MyJo Kim LLC d/b/a Aries Liquor
537. FDA-2022-H-2488-0001Complaint
538. FDA-2007-D-0369-0978Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
539. FDA-1991-P-0355-0007Tab B Application for Extension of Temporary Marketing Permit from Michael Foods, Inc…
540. FDA-2020-S-0024-1217SFC2020-001430 Oregons Wild Harvest- Oregon's Wild Harvest Astragalus Capsule- support…
541. FDA-2025-S-0024-08912025-000966 - Theralogix - Theralogix, OvaNAD - Contains nicotinamide riboside plus…
542. FDA-2024-P-2326-0003Exhibit 1
543. FDA-2012-N-1205-0003Accessible Medical Device Labeling in a Standard Content and Format - Notice of Extension…
544. FDA-1976-N-0515-0012Provisional Listing of FD&C Blue No. 2; Postponement of Closing Date
545. FDA-2018-H-3547-0001Complaint
546. FDA-2022-H-1830-0001Complaint
547. FDA-2007-D-0369-2414PSG_214759 - Draft Guidance on Treosulfan
548. FDA-2012-S-1144-0229Vitacost.com, Inc. - Smart Basics Organic Certified Acai Berry Juice Blend - Promote…
549. FDA-2025-P-7285-0001Suitability Petition from Premier Research International, LLC
550. FDA-1997-N-0152-0044The Microbial Safety of Fresh Produce Town Meeting, December 1, 1997 - Transcript
551. FDA-1977-N-0224-0135Answer Letter from FDA to Comment from The Honorable Eldon Rudd, United States House of…
552. FDA-2017-H-2288-0001CMP Complaint Issued to Homerun Oil Co., Inc. d/b/a Tesoro
553. FDA-2018-H-4359-0001Complaint
554. FDA-2004-P-0537-0010Withdrawal Letter from Hogan Lovells US, L.L.P.
555. FDA-2019-E-3166-0004Patent Term Extension Letter from FDA CDER to the U S Patent and Trademark Office
556. FDA-1996-N-0006-0002Notice of Proposed Rule re Additional Criteria and Procedures for Classifying…
557. FDA-2022-D-0466-002119 The role of parenteral antischistosomal therapy in spread HCV
558. FDA-2017-S-0024-09482017001123 - Ortho Molecular Products, Inc. - Adapten-All - Endocrine Health
559. FDA-2011-N-0754-0001Pediatric Medical Devices; Public Workshop Meeting
560. FDA-2013-P-1058-0004Interim Response from FDA CDER to IntelGenx Corporation
561. FDA-2021-N-1309-0087Reference 84 Liu Inside the Adolescent Voice 2021
562. FDA-2018-H-2757-0001Complaint
563. FDA-2025-S-0024-01982025-000277 - Europharma Inc. - Berberine MetX Enhanced Absorption - Supports overall…
564. FDA-2013-N-0001-0102Medical Gas Regulation Review; Announcement of Public Meeting
565. FDA-2004-P-0408-0002Acknowledgment Letter from FDA DMB to Lachman Consultant Services, Inc.
566. FDA-2023-H-1116-0001Complaint
567. FDA-2022-D-0467-010299 The incidence of HIV infect among men USArmy 1985 to 1991
568. FDA-2016-V-1225-0002Acknowledgement Letter from FDA DDM Dream Beamz LLC
569. FDA-2021-V-0588-0001Variance Application from NJ Smart Homes and Theater
570. FDA-2016-S-0024-0116NBTY, Inc. - Ultra Man™ 50 Plus Daily Multi - Men's health
571. FDA-2004-F-0321-0002Background
572. FDA-2003-P-0411-0002Acknowledgment Letter from FDA DMB to Public Citizen Health Research Group
573. FDA-2022-S-0024-12952022-001251 - CEDEM AG Switzerland - VitaCed Magnesium -It is an important component for…
574. FDA-2018-N-3634-0001Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation…
575. FDA-2012-N-1210-0688Request for Extension from Olsson Frank Weeda Terman Matz PC
576. FDA-2023-P-4877-0007Attachment 5 -ETODOLAC TABLETS USP- re: Suitability Petition from Pharmobedient Consulting
577. FDA-2015-H-1627-0001Complaint
578. FDA-2009-S-0607-0644Perrigo - H-E-B Ocular Vitamins - Maintain the Health of the Macula, In the Eye
579. FDA-2015-P-2962-0001Citizen Petition From Regcon Solutions LLC
580. FDA-2017-S-0023-0014NDI 980 - Anese Hydrating Elixir - Original NDI Notification
581. FDA-2018-S-0024-02432018001410 - Jarrow Formulas, Inc. - Jarrow Formulas® TMG - Reduces Homocysteine and…
582. FDA-2018-H-2267-0001Complaint
583. FDA-2022-S-0024-14972022-3143 - LifeSeasons - NeuroQ Sleep Now - Supports Restful Night Sleep and Mental…
584. FDA-2004-D-0120-0001FDA
585. FDA-2015-H-4837-0001CTP CMP Case re Michael Brainard d/b/a Rogan’s Corner
586. FDA-2014-N-0189-6381Request for Extension from Johnny Weddle Jr
587. FDA-2015-N-3469-0065Nomination from David Smith
588. FDA-1996-N-0006-0102Reference 2 - FDA, Guidance for Industry, Guideline for the Format and Content of the…
589. FDA-2008-P-0485-0002Acknowledgement Letter to Apotex Inc.
590. FDA-1981-N-0114-0023Reference 14 - "Comment No. LET22, 1981N-0114" - [Classification of Benzoyl Peroxide as…
591. FDA-1982-P-0018-0344Background Material
592. FDA-2018-N-3623-0001Fostering Medical Innovation: Voluntary Pilot Program To Streamline Review of Premarket…
593. FDA-1975-N-0012-0384FDA CDER Letter to Manufactures for OTC Topical Antiseptic Drug Products Request Labeling…
594. FDA-2015-H-3685-0001CTP CMP Case re Biz, Inc. d/b/a Shell
595. FDA-1991-N-0014-0031FDA
596. FDA-2012-N-0781-0001Requests for Nonvoting Industry Representatives, Industry Involvement in Selection…
597. FDA-2015-H-4970-0001CTP CMP Case re Square One Markets, Inc. d/b/a Square One / Exxon
598. FDA-2023-E-2247-0004Letter from U. S. Patent and Trademark Office to FDA CDER
599. FDA-2004-N-0508-0008Transcript of 11/16/2004 Public Meeting
600. FDA-2023-V-2110-0002Acknowledgment Letter from FDA DMS to Luis Paz
601. FDA-2005-N-0404-0118See FDA-2005-N-0404-0132
602. FDA-2022-P-0566-0001Citizen Petition from Ronald Brock
603. FDA-2020-S-0024-0958SFC2020-001141 NOW Foods - Lucky Vitamin, Vitamin C Powder - Supports immune system
604. FDA-2021-V-0098-0001Variance Application from Best Buy Company Inc
605. FDA-2022-H-3251-0001Complaint
606. FDA-2021-V-0570-0003Variance Approval to Avid Productions LLC from FDA CDRH
607. FDA-2023-N-3902-1446Comment from Tatyana Austin
608. FDA-2007-D-0369-2065PSG_218490 - Draft Guidance on Macitentan; Tadalafil
609. FDA-2024-H-4607-0001Complaint
610. FDA-2019-V-4951-0001Variance Application from Kyle McFarlane
611. FDA-2017-H-4096-0001CMP Complaint Issued to Dona Paola, LLC d/b/a Dona Paola / Exxon
612. FDA-2005-P-0003-0004Sandoz Inc. - Citizen Petition
613. FDA-2022-P-2425-0038Reference 35 - Christensen J. Women with chronic conditions struggle to find medications…
614. FDA-2023-H-1780-0001Complaint
615. FDA-2024-H-3092-0001Complaint
616. FDA-2024-P-3482-0004Final Response Letter from FDA CDER to Qilu Pharmaceutical (Hainan) Co., Ltd
617. FDA-2018-E-4336-0003Letter to Fish & Richardson PC from FDA CDER
618. FDA-2015-P-3876-0005The Real Cost of Dental Mercury re Citizen Petition from World Alliance for Mercury-Free…
619. FDA-2008-D-0055-0003References
620. FDA-2014-H-2070-0001Complaint
621. FDA-2009-S-0607-1101Perrigo - Western Family Vitamin D - Immune System Function
622. FDA-2013-D-0126-0006Guidance for FDA Staff; Compliance Policy Guide Sec. 100.250 Food Facility Registration…
623. FDA-1978-N-0018-15869MGF 400062_PCPC-FDA Meeting Request
624. FDA-2015-H-4255-0001CTP CMP Case re Shri Shalibhadra Inc. d/b/a Smok’s Tobacco Outlet
625. FDA-2015-H-4962-0002Complaint
626. FDA-2021-V-0889-0002Acknowledgment Letter from FDA DMS to Sunsational Signs
627. FDA-1980-N-0038-0526Letter from Ciba-Geigy Corporation to The Honorable Daniel J. Davidson (Sutherland, Asbill…
628. FDA-2018-N-4626-0068Nomination from Wedgewood Pharmacy
629. FDA-1996-P-0374-0005Supplement from The Joint Council of Immunohistochemical Manufacturers
630. FDA-1984-G-0007-0027Background Material: E-15 Synopsis
631. FDA-2024-S-0024-10982024-001979 - FLYNEW GLOBAL INC - LIVEGIS, CREATINE - Helps Build Muscle and Strength
632. FDA-2014-D-2138-0017Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance…
633. FDA-2025-E-3625-0003Letter to U. S. Patent and Trademark Office
634. FDA-2024-H-4810-0001Complaint
635. FDA-2023-S-0024-01252023-000231 - Food Market Management- Ginger Rescue Chewable Ginger Tablets - Strong…
636. FDA-2016-H-0603-0002Complaint
637. FDA-2024-H-1390-0001Complaint
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639. FDA-2016-P-3311-0003Attachment A Evidence to Support the Use of Polydextrose as a Source of Dietary Fiber in…
640. FDA-2025-V-3021-0003Variance Approval Letter from FDA CDRH to Christopher Mckenna
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643. FDA-2014-N-0189-3537Request for Extension from Anonymous
644. FDA-1992-P-0335-0003Letter from Faulding, Inc. to FDA Dockets Management Branch
645. FDA-1982-P-0018-0100Background Material
646. FDA-2015-E-3813-0007Letter from FDA CDER to U.S. Patent and Trademark Office
647. FDA-2015-H-4605-0001CTP CMP Case re Christal Investments IIII, Inc. d/b/a Le Jeune Food Store
648. FDA-2020-E-1912-0004Letter from FDA CDER to U S Patent and Trademark Office
649. FDA-2019-S-0024-08722019-002601 - --Health, Inc. - Culturelle Kids Probiotic Gummies - Supports a healthy…
650. FDA-2010-D-0589-0016See Docket FDA-2010-D-0434
651. FDA-2025-H-6295-0001Complaint
652. FDA-2008-P-0555-0002Acknowledgement Letter to Vintage Pharmaceuticals, Inc.
653. FDA-2013-V-0628-0001ELV - Application for Variance
654. FDA-1977-N-0014-0799Answer Letter from FDA to Comment from The Honorable William L. Armstrong, United States…
655. FDA-1982-P-0018-0062Background Material
656. FDA-2019-P-4448-0002Acknowledgment Letter from FDA DMS to Samuel A. Gonzalez
657. FDA-1997-S-0039-2426Perrigo - The Medicine Shoppe - Dairy Digestive Supplement - Works naturally to ease the…
658. FDA-1975-N-0012-0825Lonza Inc. Listing 16.2.11: Childbearing Potential and Urine Pregnancy Test Results All…
659. FDA-1977-N-0014-0828Answer Letter from FDA to Comment from The Honorable Adlai E. Stevenson, United States…
660. FDA-2003-E-0221-0003U.S. Patent & Trademark Office
661. FDA-2019-H-4194-0001Complaint
662. FDA-1978-N-0021-0028Transmittal sheet re letter from FDA/CDER to The Purdue Frederick Company
663. FDA-2017-E-6715-0001Patent Extension Application from Perkins Coie LLP (on behalf of Radius Health, Inc.)
664. FDA-2008-P-0197-0004FDA Response to William J. Kennick, Esq. - Petition Denial
665. FDA-2011-N-0494-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals: Data to…
666. FDA-2020-S-0024-14272020-930 - FitLife Brands Inc - D1- T Strength L-Carnitine Elite Burn - Support for fat…
667. FDA-2018-N-0663-0001Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug…
668. FDA-2014-N-0189-5856Request for Extension from Thomas D. McClirk
669. FDA-2023-S-0024-07432023-001583 - Basic Research LLC - Stress Relief: Deep Sleep Capsules - Improves gut and…
670. FDA-2021-V-0171-0002Acknowledgment Letter from FDA DMS to Krystal Clear Audio-Video Inc
671. FDA-2012-S-1144-0555Perrigo Company of South Carolina - Health Mart® - calcium - For bone and colon health
672. FDA-2024-E-0215-0003Letter from FDA CDER to U.S. Patent and Trademark Office
673. FDA-2015-V-1614-0001Variance Application From Tristan Miekas
674. FDA-2021-N-1305-0020Antimicrobial Drug Use in Companion Animals; Extension of Comment Period
675. FDA-2018-V-1651-0003Variance Amendment Request from JW North America Inc
676. FDA-2011-F-0172-0026Reference 10 - "Ogden, et al., Prevalence of Overweight, Obesity, and Extreme Obesity…
677. FDA-2015-E-4674-0006Regulatory Review Letter
678. FDA-2013-D-1156-0019Q3D Elemental Impurities Guidance for Industry
679. FDA-2019-H-0978-0001Complaint
680. FDA-2011-V-0223-0002Acknowledgement Letter to Last Chance Saloon
681. FDA-2014-N-0189-4855Request for Extension from MaryJane Kipfer-Richards
682. FDA-2025-V-1221-0001Variance Application from Wild West Lighting
683. FDA-2011-S-0932-1720Vitacost.com , Inc., d/b/a Nutraceutical Sciences Institute - NSI® Stevia Plus - Help…
684. FDA-2017-E-3592-0008Response Letter by FDA CDER re Citizen Petition
685. FDA-2010-S-0665-0016NDI Notification for AvoCetyl re NDI 642, AvoCetyl from Cyvex Nutrition
686. FDA-2009-S-0607-1276Melaleuca, Inc. - Vitality 6 (Essentials + Heart) - Heart Health
687. FDA-2023-S-0024-00522023-000059 - Reckitt - Milkflow Berry flavored drink mix - Support breast milk supply
688. FDA-1997-S-0006-1718Courtesy letter and related material from CFSAN to WuHan JianMinDaPeng Pharmaceutical…
689. FDA-2001-A-0410-0003Pennsylvania Department of Health - Letter
690. FDA-1993-D-0056-0001Draft Guideline for the Validation of Blood Establishment Computer Systems; Withdrawal of…
691. FDA-2016-D-0545-010304 Reference 3 final guidance zika-travel information
692. FDA-2010-S-0664-0704Genexis - Humulex - Eases Minor Pain and Inflammation from Overexertion or Everyday…
693. FDA-2015-S-0024-0060FitLifeBrands Inc - UltraKarbs - Support for energy
694. FDA-2016-H-0913-0002Complaint
695. FDA-1994-A-0428-0002Attachment 1 Letter from Cornell D. Cornish Law Office to FDA March 21, 1994 re: Advisory…
696. FDA-2020-V-1609-0003Variance Approval Letter from CDRH to Jeffrey Jarrett
697. FDA-2024-S-0024-05832024-001418 - Lovita Foods International Corporation - 1- Lovita Biotin 11000 mcg, 128…
698. FDA-2022-E-2206-0002Patent Extension Application from Sterne Kessler Goldstein & Fox P.L.L.C.
699. FDA-2014-D-1814-0002Draft Guidance for IndustryBacterial Detection Testing by Blood Collection Establishments…
700. FDA-2015-V-1605-0003Letter from FDA CDRH to Lucid Light Lounge
701. FDA-2002-P-0123-0009TAB 16- Report of Consultation
702. FDA-2006-E-0123-0007USPTO to Warner-Lambert Company LLC - Certificate Extending Patent Term
703. FDA-2011-D-0147-0010Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to…
704. FDA-2023-H-3172-0001Complaint
705. FDA-2024-H-4112-0001Complaint
706. FDA-2017-H-6092-0001Complaint
707. FDA-2016-H-2016-0001Complaint
708. FDA-2016-S-0024-2262Perrigo - Multiple claims - 2
709. FDA-2017-P-5592-0001Citizens Petition from International Isotopes Inc
710. FDA-2023-V-4232-0001Variance Application from Extreme Lightscapes
711. FDA-2018-H-2067-0001Complaint
712. FDA-2015-S-0024-1969NBTY - Potassium Gluconate supplements - Supports normal fluid balance between the cells…
713. FDA-2009-S-0608-0010NDI 553 - PIQ 1 - SUPPORTING & RELATED MATERIALS
714. FDA-2024-H-0586-0001Complaint
715. FDA-1982-N-0005-0029References re Comment from Miles Laboratories, Inc.
716. FDA-1975-N-0017-0045Letter from FDA/CDER to Nonprescription Drug Manufacturers Association
717. FDA-2006-P-0149-0010Citizen Petition Denial Response from FDA CDRH to Washington Legal Foundation
718. FDA-2020-E-1911-0006Letter from FDA CDER TO U.S. Patent and Trademark Office
719. FDA-2012-S-1144-0857Now Foods - Chewable C-500 Tablets - important for skin, bone, and joint health
720. FDA-1999-P-0165-0003Attachment 2 Proposed Package Insert for Gensia Sicor's Ifosfamide Injection re: Citizen…
721. FDA-2006-S-0544-0004NDI 304 - Extract of Garcinia Cambogia (Cool Water Trim) from Shannon Minerals Inc.
722. FDA-2012-D-0523-0014Refuse to Accept Policy for 510(k)s Guidance for Industry and Food and Drug Administration…
723. FDA-2012-V-0125-0002Acknowledgement Letter to Texas Pinball
724. FDA-2022-S-0024-05132022-000523 - Reliance Vitamin Co. - Reliance Private Label Collagen Peptides Vanilla…
725. FDA-2016-H-4073-0001Complaint
726. FDA-2005-S-0518-0011NDI 258 - Betaphine (Isopropyl octopamine) - Original NDI Notification
727. FDA-2024-H-2594-0001Complaint
728. FDA-2023-V-1841-0001Variance Application from Michael Weiser
729. FDA-2004-V-0430-0001HFA-305 to Robco Inc dba The Waterwaters Pub
730. FDA-2003-P-0011-0002Letter from FDA CDER to Lachman Consultant Services
731. FDA-2016-V-1774-0004Variance Approval Letter from FDA CDRH to Dominant Records
732. FDA-2000-D-0130-0029HFC-240 & Scientific Software Inc 8/2/01 - Memorandum of Meeting
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735. FDA-2022-V-0578-0003Variance Approval Letter from FDA CDRH to Daniel Kubacak
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737. FDA-2025-P-6893-0002Acknowledgment Letter from FDA DMB to Sagent Pharmaceuticals
738. FDA-2024-H-2719-0001Complaint
739. FDA-1977-N-0005-0006The Stockman's Handbook Part 1 of 5 - Background Information
740. FDA-2014-H-0382-0001Complaint
741. FDA-2016-P-2467-0003Withdrawal letter from Actavis LLC to FDA
742. FDA-2024-H-4973-0001Complaint
743. FDA-2001-N-0175-0002National Transportation Safety Board Joint Meeting Transcript of meeting held 11/14/01…
744. FDA-2014-N-0189-3169Request for Extension from Anonymous
745. FDA-2006-N-0414-0025Transcript of February 7, 2007 Public Meeting
746. FDA-2016-H-3096-0001Complaint
747. FDA-2017-N-1003-0024Attachment 2 Sample Site Visit Agenda re: Request for Participation (ELP) from Blue Cross…
748. FDA-1982-N-0011-0094Background Material
749. FDA-2017-H-4461-0001CMP Complaint Issued to Dollar Express Stores LLC d/b/a Family Dollar 8926
750. FDA-2020-E-1912-0001Letter from U.S. Patent and Trademark Office to FDA CDER
751. FDA-2017-H-1413-0001CMP Complaint Issued to Prit LLC d/b/a Right Fuel and Food
752. FDA-2011-S-0932-0435Letter from NBTY, Inc.
753. FDA-2016-V-1244-0001Variance Application from Steven Marshall
754. FDA-2010-P-0540-0011Exhibit F - "Clinical Review, Division of Anesthesia, Analgesia, and Rheumatology…
755. FDA-2024-H-3317-0001Complaint
756. FDA-2021-V-0444-0003Variance Approval Letter from FDA CDRH to LMC Home Entertainment Ltd
757. FDA-2022-H-1141-0001Complaint
758. FDA-2019-N-3065-0191Reference 189 - The Health Consequences of Smoking_Cardiovascular Disease, 1983 re Tobacco…
759. FDA-1999-N-0134-0085Risk Assessment
760. FDA-2013-V-0395-0002Acknowledgement Letter to Pro Sound Electrical, Inc.
761. FDA-2023-H-3810-0001Complaint
762. FDA-2015-H-0144-0001Complaint
763. FDA-2015-H-4465-0001CTP CMP Case re Claytongage, Inc. d/b/a Mason Smoke Shak
764. FDA-2012-P-0904-0316Supplement from Citizens for Health
765. FDA-1984-G-0007-0296Background Material: E-33 Curriculum Vitae
766. FDA-2023-P-0344-0007Exhibit 021-024 RE Citizen Petition from McDermott Will & Emery, LLP
767. FDA-2009-N-0221-0005Agency Information Collection Activities; Proposed Collection; Submission for Office of…
768. FDA-1990-P-0363-0003American Olive Oil Association - Amendment
769. FDA-2013-N-0375-0009Agency Information Collection Activities; Announcement of Office of Management and Budget…
770. FDA-2018-D-1216-0020Electronic Common Technical Document; Data Standards; Specifications for Electronic Common…
771. FDA-2007-E-0278-0013FDA/CDER to Covington & Burling LLP (Merck & Co., Inc.) - Letter
772. FDA-2019-H-2651-0001Complaint
773. FDA-2013-D-0362-0002Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for…
774. FDA-2018-H-0118-0001Complaint
775. FDA-1980-N-0049-0165Background Information for Notice of Withdrawal of 12/29/04 - Tab 2: January 8, 2004…
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777. FDA-2011-N-0002-0086Request for Notification From Consumer Organizations Interested in Participating in the…
778. FDA-2015-V-1827-0003Variance Approval from FDA CDRH to Cabrillo Entertainment
779. FDA-2018-H-4438-0001Complaint
780. FDA-2021-P-1296-0001Suitability Petition from Lachman Consulting Services Inc.
781. FDA-2007-D-0369-2179PSG_019845 - Draft Guidance on Betaxolol Hydrochloride
782. FDA-1976-N-0518-0003Determination of Inapplicability for Proposed Policy, Practices, and Procedures…
783. FDA-2004-P-0026-0002HFA-305 to Lachman Consultant Services, Inc.
784. FDA-2024-H-1508-0001Complaint
785. FDA-2015-S-0024-0815Perrigo Company of South Carolina - Health Mart® - One Daily - Specialized formula With…
786. FDA-2015-D-3399-0017Reference 14 Guidance for Industry and Investigators Safety Reporting Requirements for…
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791. FDA-1982-P-0018-0105Background Material
792. FDA-2016-H-1585-0001Complaint
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796. FDA-2006-D-0031-0023Request for Extension of the Comment Period from Biotechnology Industry Organization (BIO)
797. FDA-2007-D-0369-0078Draft Guidance on Iron Sucrose; re on Bioequivalence Recommendations for Iron Sucrose…
798. FDA-1995-S-0036-0118ProTECT Emergency Neurosciences Department of Emergency Medicine (Emory University Scool…
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800. FDA-2012-P-1007-0001Public Citizen - Citizen Petition
801. FDA-2016-S-0024-0817Platinum Naturals Inc. - Total Vision Care™ - Supports eye health
802. FDA-1981-N-0083-0103Letter from Dr. F. Leo Kauffman to Norman Singer
803. FDA-2022-P-0896-0002Acknowledgment Letter from FDA DMS to Greenberg Traurig
804. FDA-2017-H-6610-0001Complaint
805. FDA-2006-P-0019-0007Citizen Petition Supplement from Wyeth Pharmaceuticals
806. FDA-2022-V-1097-0001Variance Application from Cody Stoothoff
807. FDA-2024-H-3749-0001Complaint
808. FDA-2013-N-1317-0269Reference 17-25 CEG Comment re Final Determination Regarding Partially Hydrogenated Oils
809. FDA-1977-N-0002-1600Answer Letter from FDA to Comment from National Cattlemen's Association
810. FDA-2013-N-0747-0036Supplement from National Pecan Shellers Association (NPSA)
811. FDA-1994-P-0043-0011FDA
812. FDA-2008-V-0198-0008FDA/CDRH Response to Lightwave International, Inc. - Approval for Variance
813. FDA-2000-N-0284-0003Dietary Supplements Containing Ephedrine Alkaloids; Availability; Reopening of Comment…
814. FDA-2023-P-2115-0151Citizen Petition Interim Response from FDA CDRH to Americans for Responsible Technology
815. FDA-2025-H-5674-0001Complaint
816. FDA-2014-N-0189-3186Request for Extension from Anonymous
817. FDA-2011-V-0639-0003Best Entertainers - Approval for Variance
818. FDA-2014-H-0043-0001Complaint
819. FDA-1976-N-0027-0216Supplement from Consumer Healthcare Products Association - Appendix 2: Part 18
820. FDA-2011-N-0920-0012Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human…
821. FDA-2023-S-0024-05232023-001066 - Viva Naturals Inc. - Viva Naturals Inc., High-Potency Vitamin D3 30 count…
822. FDA-2007-D-0369-0790PSG_019594 - Draft Guidance on Ursodiol re Product-Specific Guidances; Draft and Revised…
823. FDA-2003-S-0732-0129NDI 165 - Ganoderma lucidum Mushroom Extract from Gano Excel (U.S.A.) Inc.
824. FDA-1982-N-0005-0067Appendix I re Supplement from Adria Laboratories
825. FDA-2018-P-1949-0043Fn 50_Nocdurna sublingual wafers_Product Information re Citizen Petition from Avadel…
826. FDA-2005-N-0030-0004Supporting Statement re Agency Information Coftection Activities; Announcement of Office…
827. FDA-2022-N-2390-0061Letter from FDA CDER to Morphy
828. FDA-2022-N-2390-0138Exhibit 2
829. FDA-1984-G-0325-0019Letter from Protan Biopolymer A.S. to FDA CFSAN
830. FDA-2016-H-2670-0001Complaint
831. FDA-2023-H-2398-0001Complaint
832. FDA-2014-E-0934-0006Letter from FDA CDER to the U.S. Patent and Trademark Office
833. FDA-1995-S-0036-0217Public Disclosure from Vascular Solutions, LLC
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835. FDA-2017-H-4223-0001CMP Complaint Issued to Bill’s Imperial, Inc. d/b/a Fas Trip
836. FDA-2021-P-1048-0002Acknowledgment Letter from FDA DMS to Pet Schooled
837. FDA-2015-S-0024-1409Perrigo Co - Health Mart®- Complete Women 50+ - calcium & vitamin D help maintain strong…
838. FDA-2025-H-2024-0001Complaint
839. FDA-2015-S-0024-1985One Giralda Farms - Centrum® Liquid Adults Multivitamin/Multiminera Supplement - Energy
840. FDA-2018-P-2104-0003Attachment 1- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations…
841. FDA-2019-H-2508-0001Complaint
842. FDA-2001-P-0121-0001HFD-1 to Ben Venue Laboratories Inc & AAC Consulting Group
843. FDA-2013-N-0402-0023Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives; Public Hearing…
844. FDA-2007-D-0369-1140PSG_205649 - Draft Guidance on Dapagliflozin; Metformin Hydrochloride
845. FDA-2023-U-3194-0001Complaint
846. FDA-2025-S-0024-04952025-000580 - International Vitamin Corporation - SmartCare Wellness Healthy Tears Support…
847. FDA-2010-S-0664-1993Perrigo Company - Walgreens A thru Z Select - Eye Health
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849. FDA-2023-E-3058-0003Letter from FDA CDER to U.S. Patent and Trademark Office
850. FDA-2018-S-0024-04312018001555- International Vitamin Corporation- MULTIPLE CLAIMS (13)
851. FDA-2010-P-0112-0003Exhibit 1 - Reference Listed Drug Package Insert Oxytocin Injection, USP re…
852. FDA-1995-N-0054-13774Background Material for NFR 1
853. FDA-1999-N-0114-0006Reference from FDA/CBER re OMB Changes
854. FDA-2017-H-4599-0001CMP Complaint Issued to Malincho, Inc. d/b/a Prestige Liquor
855. FDA-2015-H-4038-0001CTP CMP Case re Pars Food Mart, Inc.
856. FDA-2005-D-0455-0003Guidance
857. FDA-2021-S-0024-00282021-000039- Frontier Co-Op - Frontier Co-Op, Rose Hips (Rosa canina) - Supports Joint…
858. FDA-2007-H-0094-0034FDA/Administrative Law Judge - Order
859. FDA-2019-H-2198-0001Complaint
860. FDA-2017-H-3864-0001CMP Complaint Issued to Joe Walker d/b/a Hillbilly Gas Mart
861. FDA-2025-S-0024-03962025-000480 - Piping Rock Health Products - HEB Triple Strength Glucosamine Chondroitin…
862. FDA-2016-S-0024-24012016000612-Maximum Human Performance - MHP Up Your Mass - High Protein Super Weight Gainer
863. FDA-1977-N-0022-0094Reference 13- Berg, D. E., J. Davies, B. Allet, and J. D. Rochaix, "Transposition of…
864. FDA-2014-H-2034-0001Complaint
865. FDA-2011-S-0932-0386Letter from Solstice Medicine Company
866. FDA-2023-H-4497-0001Complaint
867. FDA-1990-S-0006-0239HFD-7 - Memo - Ted Sherwood
868. FDA-1999-N-0134-0011Risk Assessment
869. FDA-2011-N-0183-0001Debarment Orders: Hung Ta Fan
870. FDA-2010-S-0665-0109Amendment re NDI 648, Proselem from Laboratoire Vita Api
871. FDA-2019-D-0363-0014Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or…
872. FDA-2017-D-5966-0013Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff…
873. FDA-2022-D-1729-0001Migraine: Developing Drugs for Acute Treatment; Draft Guidance for Industry; Availability
874. FDA-2011-F-0172-0485Members of Congress of the United States to the Commissioner for Foods and Drugs, July 26…
875. FDA-1982-N-0005-0080Pharmacokinetic Data Analysis on Post Surgical Dental Pain (III. Pharmacokinetic Report)…
876. FDA-2004-N-0187-0002Agency Information Collection Activities; Submission for Office of Management and Budget…
877. FDA-2008-N-0567-0105020 Reference 19 - Imported Lassa Fever --- New Jersey, 2004
878. FDA-1997-S-0039-1540NOW Foods - Life Balance™ High Potency CoQ10 400 mg Softgels - Coenzyme Q10, also called…
879. FDA-2024-H-4917-0001Complaint
880. FDA-2024-S-0024-07092024-001536 - Kaged Muscle - KAGED, Pre-Workout Stim-Free- PROMOTES FOCUS
881. FDA-2022-E-0659-0006Letter from U. S. Patent and Trademark Office to FDA CDER
882. FDA-2018-P-2104-0001Citizen Petition from Nostrum Pharmaceuticals, LLC.
883. FDA-1994-F-0431-0003Finding of No Significant Impact for Shepherd Color Company
884. FDA-2016-H-2355-0001Complaint
885. FDA-2022-V-0037-0002Acknowledgment Letter from FDA DMS to Nelsound
886. FDA-2022-E-2012-0001Letter from U S Patent and Trademark Office
887. FDA-1977-N-0014-0820Answer Letter from FDA to Comment from The Honorable Bill Hefner, United States House of…
888. FDA-2005-N-0237-0002Agenda for May 23, 2005 Meeting
889. FDA-2015-H-3961-0002Complaint
890. FDA-2016-H-0955-0002Complaint
891. FDA-2021-V-1340-0002Acknowledgment Letter from FDA DMS to X-Clusive Promotions
892. FDA-1977-P-0010-0006Withdrawal of Certain Pre-1986 Proposed Rules; Final Action - Withdrawal
893. FDA-2012-S-1144-1308VitaTech International, Inc. - Advanced Strength CinSulin - Cinnamon concentrate 10:1…
894. FDA-2015-S-0024-3475Hum Nutrition Inc. - Big Chill - Helps you cope with & remove the signs of stress
895. FDA-2007-D-0369-0538PSG_210833 - Draft Guidance on Clobazam
896. FDA-2025-H-7421-0001Complaint
897. FDA-1975-N-0012-0483FDA CDER Letter to Manufactures for OTC Topical Antiseptic Drug Products Request Labeling…
898. FDA-2019-H-4087-0001Complaint
899. FDA-2005-P-0066-0002Acknowledgment Letter from FDA DDM to McGuff Pharmaceuticals Inc.
900. FDA-2014-D-0055-0220Reference 07-000 - List of References
901. FDA-2017-M-5969-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
902. FDA-2024-N-1111-0001Submission of Food and Drug Administration Import Data in the Automated Commercial…
903. FDA-2016-N-3118-0324197_FDA Study Data
904. FDA-2016-H-1632-0001Complaint
905. FDA-2018-P-3076-0004Response Letter from FDA CDER to Dr. Joseph Purita
906. FDA-2014-V-0322-0002Acknowledgement Letter from FDA DDM to Spatz Enterprises
907. FDA-2016-P-1180-0037Appendix 6 Sonnenberg Koch Epidemiology of Constipation in the United States re APPENDIX…
908. FDA-2019-E-3014-0004Letter to U S Patent and Trademark Office
909. FDA-2010-P-0526-0003Acknowledgement Letter to Lachman Consultant Services, Inc.
910. FDA-2007-D-0369-0837PSG_020831- Draft Guidance on Formoterol Fumarate
911. FDA-2008-N-0567-0074003 Reference 2 - HIV Surveillance Report 2015
912. FDA-2011-D-0611-0053Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price…
913. FDA-2016-P-1169-0009Appendix B re Petition for Reconsideration from e5 Pharma, LLC
914. FDA-2013-N-0001-0007Global Quality Systems--An Integrated Approach to Improving Medical Product Safety Public…
915. FDA-2011-N-0655-0004Generic Animal Drug Alliance (GADA) Public Meeting dated November 7, 2011
916. FDA-2023-U-2294-0001Complaint
917. FDA-2017-H-4481-0001CMP Complaint Issued to Gopinath Enterprises Inc. d/b/a Li’l Saver Market
918. FDA-1994-P-0041-0224BACKGROUND
919. FDA-1996-N-0468-0016Letter from Animal Health Institute to FDA DDM
920. FDA-1992-N-0024-0002Letter from FDA to Mr. Jacob H. Rivers
921. FDA-2018-P-1310-0002Acknowledgment Letter from FDA DDM to Vertice Pharma Management Corp
922. FDA-2011-S-0932-0158Letter from Waterpure, Inc.
923. FDA-2024-H-1123-0001Complaint
924. FDA-2017-H-3444-0001CMP Complaint Issued to Amaan Enterprise Inc. d/b/a United Gas C-Store
925. FDA-2019-H-1461-0001Complaint
926. FDA-2017-H-5496-0001Complaint
927. FDA-2014-N-1051-0644644 7694105 survey subject r2018_Redacted
928. FDA-2020-H-0342-0001Complaint
929. FDA-2022-S-0024-13522022-001916 - TSI USA LLC- Tailored Script, Maca- support healthy reproductive health
930. FDA-2024-N-5471-0632Reference 630 Gaalema Potential Moderating Effects of 2019
931. FDA-2007-E-0278-0015U.S. Patent and Trademark Office - Letter
932. FDA-1998-N-0042-0001Report of the Commission on Dietary Supplement Labels
933. FDA-2011-S-0932-2024Vitacost.com, Inc. d/b/a Nutraceutical Sciences Institute - NSI Ashwagandha Extract - May…
934. FDA-1993-G-0218-0203Section 2/Subsection F of Reference 22 - 21 CFR 172.892, “Food Starch-modified," Code of…
935. FDA-2023-H-5386-0001Complaint
936. FDA-2009-S-0607-0855Traditional Medicinals, Inc. - Everyday Detox - Promote Healthy Liver Function
937. FDA-2020-P-2067-0005Attachment 3 re Suitability Petition from Hyman, Phelps & McNamara, PC
938. FDA-1977-N-0014-1009Answer Letter from FDA/Office of Legislative Services to Honorable Richard S. Schweiker…
939. FDA-2006-V-0217-0002HFA-305 to Mero Productions
940. FDA-2015-N-3037-00770073_R_IND79010_A0030_Status2_Corrected-CSR_Narrative-clean
941. FDA-2020-E-2269-0004Letter from U.S. Patent and Trademark Office to FDA CDER
942. FDA-2008-M-0593-0001Boston Scientific Corporation [TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System…
943. FDA-2007-D-0369-1384PSG_020771 - Draft Guidance on Tolterodine Tartrate
944. FDA-1977-N-0022-0044Reference 111- Walton, J. and C. E. Smith, "Transfer of Ent Plasmids,"Microbial Genetics…
945. FDA-2018-H-0594-0001Complaint
946. FDA-2022-H-1159-0001Complaint
947. FDA-2015-D-3056-0001Distributor Labeling for New Animal Drugs; Draft Guidance for Industry; Availability
948. FDA-2017-P-6923-0001CONFIDENTIAL Citizen Petition from Zydus Noveltech Inc
949. FDA-2020-S-0024-00482020-000059 - SmartyPants, Inc - Men Formula - Supports good health, Thyroid, Bones
950. FDA-2014-H-0778-0001Complaint
951. FDA-2024-P-4934-0007Response Letter from FDA CDER to Hyman, Phelps & McNamara, P.C.
952. FDA-2019-H-4987-0001Complaint
953. FDA-2018-H-4571-0001Complaint
954. FDA-2016-H-3890-0001Complaint
955. FDA-2017-H-3318-0001CMP Complaint Issued to Family Dollar Stores of Florida, LLC d/b/a Family Dollar
956. FDA-1992-G-0275-0062Section 1/Reference 20 - (Mineral) Analysis of 88-89 Oven-Dried Pressed Pulp re Sugar Beet…
957. FDA-2013-V-1342-0003FDA/CDRH Response to LyonLabs, LLC - Apploval of Variance
958. FDA-2011-P-0637-0003FDA/CDER Interim Response to Alliance for Natural Health USA - Letter
959. FDA-1977-N-0002-1371Answer Letter from FDA/Office of Legislative Services to Honorable Lawton Chiles, United…
960. FDA-2024-H-5573-0001Complaint
961. FDA-2015-N-3469-0042Nomination from Triangle Compounding Pharmacy, Inc.
962. FDA-2004-P-0406-0007Acknowledgment Letter from FDA DMB to Illinois Attorney Generals Office
963. FDA-2024-E-3864-0002Patent Extension Application from The Firm of Hueschen and Sage PLLC (on behalf of…
964. FDA-2014-N-2235-0250Request for Extension from Diana Reeves
965. FDA-1990-G-0398-0045Letter from The NutraSweet Co., to FDA CFSAN
966. FDA-2020-D-0957-0104104-Guidance-for-Industry--Guidance-Document-For-Nonprescription-Sunglasses
967. FDA-2024-H-2373-0001Complaint
968. FDA-2014-N-0189-34532Request for Extension from Anonymous
969. FDA-2014-H-0454-0001Complaint
970. FDA-2013-E-0681-0006Letter from FDA/CDER to U.S. Patent and Trademark Office
971. FDA-2012-S-1144-1729Perrigo Company of South Carolina - Target up & up®-Vitamin E - Helps support heart…
972. FDA-2023-S-0024-03772023-000760 - Metagenics - Chewable High ADEK with Iron - Great for individuals following…
973. FDA-2014-N-0189-10578Request for Extension from Kathleen Falcone
974. FDA-2014-H-0115-0001Complaint
975. FDA-2025-P-2980-0002Acknowledgement Letter from FDA DMB to Premier Research Consulting, LLC
976. FDA-2021-V-0972-0001Variance Application from Kirk Bengtzen
977. FDA-1977-N-0025-0149Background Material-Reference 1
978. FDA-2018-S-0024-07082018-5195 Flora Inc.- Flor-Essence- supports the whole body in its natural elimination…
979. FDA-2016-N-1111-1641Attachment 2-2. JRC Consent Form for GED 4_v01-15-2014 re: Comment from Judge Rotenberg…
980. FDA-1997-S-0039-2760Perrigo - Meijer - Glucosamine Chondroitin - Helps rebuild joints
981. FDA-2015-N-0648-0008Reference 09- Comments from AARP to the Draft Guidance Documents on Biosimilar Product…
982. FDA-2001-P-0002-0003Citizen Petition Denial Letter from FDA CFSAN to Hodgson Mill
983. FDA-2015-N-0101-0395Reference 11-168 - FDA-1975-N-0012-0192 --- CP10 Volume_I_Tab_2_Introduction re Safety and…
984. FDA-2016-E-3305-0006Determination of Regulatory Review Period for Purposes of Patent Extension; PROVAYBLUE
985. FDA-1997-S-0006-2202Courtesy letter and related material from HFP to HepAssure
986. FDA-2025-P-1132-0006Attachment 4 - FDA response to Docket FDA-2019-P-3022
987. FDA-2003-D-0302-0003Supporting Document for Guidance Levels for Radionuclides in Domestic and Imported Foods
988. FDA-2004-P-0156-0002Acknowledgment Letter from FDA DMB to Intervet, Inc.
989. FDA-2008-N-0038-0028Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
990. FDA-2020-E-1820-0001Letter from U.S. Patent and Trademark Office to FDA CDER
991. FDA-2005-D-0384-0005Guidance
992. FDA-2020-H-0092-0001Complaint
993. FDA-2023-H-4946-0001Complaint
994. FDA-2015-S-0024-0078NBTY Inc - Odorless Garlic supplements under the H-E-B label - Supports heart and…
995. FDA-2014-V-0804-0003Variance Approval from FDA CDRH to PACIFIC SCIENCE CENTER
996. FDA-2004-P-0339-0024References for Citizen Peition Response
997. FDA-2023-E-3237-0005Letter to U.S. Patent and Trademark Office
998. FDA-2005-N-0474-0004Agency Information Collection Activities; Submission for Office of Management and Budget…
999. FDA-2016-S-0024-0243Source Naturals - Maqui Berry - This superfruit tablet provides an extract of the…
1000. FDA-2007-N-0475-0030Attachment 4 - "Edward Nieshoff, MD - Correspondence" - [Shire Pharmaceuticals - Comment]…