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Continuing the Regulations.gov documents list, 1000 records per page, after FDA-2010-E-0039-0003.

1. FDA-2014-N-0189-5072Request for Extension from Anonymous
2. FDA-2019-V-5226-0002Acknowledgement Letter from FDA DMS to Shiras Planetarium
3. FDA-2019-V-4325-0003Variance Approval Letter from FDA CDRH to Bryan Eudy
4. FDA-2021-S-0024-13862021-2398 Waterpure dba Purity Products - MULTIPLE CLAIMS (5)
5. FDA-2011-P-0292-0003Interim Response to Actavis Inc. - Letter
6. FDA-2023-H-4084-0001Complaint
7. FDA-2011-S-0932-1837NBTY, Inc. - Melatonin - Sleep Support
8. FDA-1976-N-0525-0010FDA/Office of General Council
9. FDA-2015-V-2050-0001Variance Application from Animal Entertainment
10. FDA-2010-S-0664-0016Perrigo - Exchange Select Glucosamine Chondroitin - Rebuild Cartilage and Lubricate Joints
11. FDA-2009-P-0289-0003Exhibit 2 - "Hearing Before the Subcommittee on Health and Environment of the Committee on…
12. FDA-2012-P-1251-0001Gordon Johnston Regulatory Consultants, LLC - Citizen Petition
13. FDA-2002-D-0093-0001Draft Guidance for Industry on Liposome Drug Products: Chemistry, Manufacturing, and…
14. FDA-2023-V-4741-0002Acknowledgement Letter from FDA DMS to Lightscape Lighting & Equipment
15. FDA-2014-N-0189-6242Request for Extension from Alisa B.
16. FDA-2017-P-4255-0006Petition Approval Letter
17. FDA-2013-E-0410-0003Letter to U. S. Patent and Trademark Office
18. FDA-2003-D-0089-0048Background Material
19. FDA-2022-D-0467-002825 Rec-Donor-Elig-Reduce-Risk-HIV-Transm-by-Blood-Final May 2023
20. FDA-2020-D-1057-0009Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or…
21. FDA-2001-N-0178-0002Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major…
22. FDA-2018-E-2590-0003Letter from U S Patent and Trademark Office
23. FDA-2009-V-0307-0002Acknowledgement Letter to Guangzhou Able Entertainment Light Equipment Co., LTD
24. FDA-2019-H-1575-0001Complaint
25. FDA-2005-D-0224-0003Guidance
26. FDA-2012-P-0826-0003Petition Denial Response Letter
27. FDA-2000-N-0112-0130Alliance for Microbicide Development - Testimony
28. FDA-2007-D-0369-2329PSG_209241 - Draft Guidance on Valbenazine Tosylate
29. FDA-2012-N-0194-0001Agency Information Collection Activities; Proposals, Submissions, and Approvals…
30. FDA-2009-N-0294-0616Tab 4 - Federal State & Local Government Collaboration - [University of California San…
31. FDA-2016-H-0449-0001CTP CMP Case re Everest Enterprises, Inc. d/b/a 7-Eleven Store 35979A
32. FDA-2007-P-0182-0007Sanofi Aventis U.S. Inc. - Appendix B - Excerpt from bioavailability study
33. FDA-2025-H-6828-0001Complaint
34. FDA-2009-S-0607-0364Perrigo - Good Neighbor Pharmacy Daily Prenatal - Support Healthy Fetal Brain and Eye…
35. FDA-2016-H-3460-0001Complaint
36. FDA-2015-V-4782-0001Variance Application from Mirror Image Photography
37. FDA-2011-N-0922-0288Reference18 - Codex Alimentarius Commission, "General Principles of Food Hygiene, CAC/RCP…
38. FDA-2007-D-0369-1377PSG_017443 - Draft Guidance on Dantrolene sodium
39. FDA-2024-V-2649-0001Variance Application from Victoria Berger
40. FDA-2016-V-2484-0003Approval letter for FDA CDRH to RED CUBE PRODUCTIONS LLC
41. FDA-2016-S-0024-0855Perrigo - Walgreens Finest Nutrition - SAM-e - HEALTHY MOOD
42. FDA-2022-H-1824-0001Complaint
43. FDA-2024-H-3853-0001Complaint
44. FDA-2019-H-5417-0001Complaint
45. FDA-1997-S-0039-1057Perrigo - Multiple claims - 2
46. FDA-1984-N-0259-0357Certificate of Service re: Mead Johnson Application for Limited Additional Oral Direct…
47. FDA-2019-H-1019-0001Complaint
48. FDA-2016-H-2699-0001Complaint
49. FDA-2011-N-0003-0074Withdrawal of Approval of New Animal Drug Applications
50. FDA-2024-S-0024-02442024-000858 - Bloom Nu LLC - Greens & Superfoods- Promotes Energy
51. FDA-2010-S-0664-1175Bayer Corporation Consumer Care - One A Day Menopause Formula Multivitamin/Multimineral…
52. FDA-2004-V-0289-0002Acknowledgement Letter to Linden Laser Systems
53. FDA-2014-N-0189-5732Request for Extension from Anonymous
54. FDA-2021-S-0024-08692021-001138 - Beijing Kingbird Pharmaceutical Technology Development Co.Ltd…
55. FDA-2000-P-0134-0004State of New York Office of the Attorney General - Withdrawal of Citizen Petition
56. FDA-1998-F-0090-0002Background Material
57. FDA-2010-S-0664-0969Life Zone Inc. - Kela Zinc - Improve Your Health
58. FDA-1993-P-0178-0004Citizen Petition from Abbott Laboratories
59. FDA-2007-P-0186-0006Citizen Petition from Perdue Pharma LP
60. FDA-2024-S-0024-08592024-001732 - Harmony Foods LLC. - HEB Melatonin Gummies 5mg 60ct - Helps promote restful…
61. FDA-1980-N-0038-0617EXHIBIT G-2.9 - Patient report forms from Carpenter Study
62. FDA-1976-N-0476-0506Memorandum of Telephone Conversation between Dr. Don Howard (G. D. Searle and Company) and…
63. FDA-2014-S-0024-0581Bioterra Herbs (Mental Focus) - Letter
64. FDA-2020-V-2160-0002Acknowledgment Letter from FDA DMS to Rick Phillips
65. FDA-2012-N-1210-1001Reference 81 USDA and HHS_1995 Dietary Guidelines re Food Labeling: Revision of the…
66. FDA-2013-D-0880-0051Reference 5.3 CDC Eat right re Frequently Asked Questions About Medical Foods; Second…
67. FDA-2017-V-5730-0006Appendix D re Variance Request from JW North America Inc
68. FDA-2010-E-0663-0008Letter from U.S. Patent and Trademark Office to Boston Scientific Corporation
69. FDA-2025-H-7352-0001Complaint
70. FDA-2011-S-0932-2753Perrigo Company of South Carolina - CareOne - Prenatal - supply important nutrients to…
71. FDA-2017-S-0024-0157Bluebonnet Nutrition Corp 1, Beautiful Ally™ Biotin I 0,000 meg Capsules, support for…
72. FDA-2021-V-0779-0002Acknowledgment Letter from FDA DMS to Driven Garage
73. FDA-2008-P-0507-0008Acknowledgement Letter to Shire Pharmaceuticals, Inc. - Correction
74. FDA-1993-G-0218-0508Revised Cover Letter to FDA/CFSAN from Canadian Harvest, U. S. A., L. P.
75. FDA-1980-N-0067-0003Letter from FDA CDER to Nonprescription Drug Manufacturers Association
76. FDA-2025-H-0299-0001Complaint
77. FDA-2009-N-0666-0003New Animal Drugs in Genetically Engineered Animals
78. FDA-2023-N-3902-0912Comment from Carmen English
79. FDA-2024-S-0024-12232024-002104 - Beijing Tong Ren Tang Co Ltd Tong Ren Tang Pharmaceutical Factory- TRT…
80. FDA-2016-H-4242-0001Complaint
81. FDA-2016-S-0024-0971Nordic Naturals - Vitamin D3 Gummies KIDS - Bone Health; Mineral Absorption; Healthy…
82. FDA-2011-S-0932-1005Perrigo Company of South Carolina (TopCare & CareOne Cranberry Supplements) LET28503…
83. FDA-2021-S-0023-0020NDI 1190 - Cofactor Raphanin (CoR) - Original NDI Notification
84. FDA-1975-N-0012-0528Appendix B: Assessment of the Developmental and Reproductive (DART) Database for…
85. FDA-2002-P-0165-0001Notice of Determination
86. FDA-2022-H-3349-0001Complaint
87. FDA-2003-P-0011-0001Acknowledgment Letter from FDA DMB to Lachman Consultant Services, Inc.
88. FDA-2014-H-2182-0001Complaint
89. FDA-1978-N-0018-0843Reference 1 - FDA Guidance_2018_Enforcement Policy - OTC Sunscreen Drug Products Marketed…
90. FDA-2015-N-2002-2038Request for Extension from Medical Information Working Group (MIWG)
91. FDA-2017-H-5323-0001Complaint
92. FDA-2019-E-5658-0007Notice of Final Determination and Requirement for Election
93. FDA-2025-H-6053-0001Complaint
94. FDA-2020-N-1850-0001Instructions for Submitting Comments
95. FDA-2020-S-0024-04412020-000557 Pharmavite LLC - Nature Made Calcium 500 mg with D3 Gummies - support strong…
96. FDA-2021-S-0024-03392021-000549 New Generation Wellness Inc - L-Glutathione 500 mg Veg Capsule - provides…
97. FDA-2009-S-0607-1137Perrigo - Onesource 45 Plus Multi - Supports Heart, Eye & Bone Health
98. FDA-2017-H-6651-0001Complaint
99. FDA-2023-E-2604-0002Patent Extension Application from FISH & RICHARDSON P.C. (on behalf of Amylyx…
100. FDA-2011-S-0932-2676NBTY, Inc. - Fish Oil - Heart Support
101. FDA-2018-D-3462-0002Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription…
102. FDA-2012-V-1097-0001DJ DISCO VINNIE - Application for Variance
103. FDA-2023-H-0021-0001Complaint
104. FDA-2011-D-0799-0001Draft Guidance for Industry: Use of Nucleic Acid Tests on Pooled and Individual Samples…
105. FDA-2024-V-4286-0002Acknowledgment Letter from FDA DMS to Laser Kid Productions
106. FDA-1997-S-0006-0298HFS-22 to Action Labs - Letter - Let 8
107. FDA-2015-S-0024-0899Perrigo Co - Health Mart®- Complete Women, Signature Care™ - Century Women - Skin, Hair &…
108. FDA-2024-E-4369-0003Letter from FDA CDER to U. S. Patent and Trademark Office
109. FDA-2022-N-1894-0005Agency Information Collection Activities; Proposed Collection; Comment Request; Yale-Mayo…
110. FDA-2020-E-1900-0002Patent Term Application Extension from BALVERSA (erdafitinib) on behalf of Pyrazolyl…
111. FDA-2024-P-4645-0001Suitability Petition from Pharmobedient Consulting, LLC
112. FDA-2025-H-0107-0001Complaint
113. FDA-2020-V-0744-0001Variance Application from Brach Burdick
114. FDA-1984-N-0259-0401Certificate of Service
115. FDA-2024-H-4319-0001Complaint
116. FDA-2025-H-0266-0001Complaint
117. FDA-2024-P-3090-0006Attachment 4 - ZEBINIX Oral Suspension Label approved by the European Medicines Agency
118. FDA-2013-N-0879-0011Agency Information Collection Activities; Submission for Office of Management and Budget…
119. FDA-2025-V-3322-0002Acknowledgment Letter from FDA DMB to Wooksville, Inc
120. FDA-2023-V-3295-0002Acknowledgment Letter from FDA DMS to Mountain West Distributors
121. FDA-2011-D-0893-0008Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and…
122. FDA-2007-E-0282-0005FDA/CDER to the USPTO - Letter
123. FDA-2012-S-1144-2526EuroPharma Inc - Vitamin D3 - Supports overall health, strong bones, teeth, and immune…
124. FDA-2016-H-4226-0001Complaint
125. FDA-2007-D-0369-1229PSG_018154 - Draft Guidance on Minoxidil
126. FDA-2003-E-0325-0007U.S. Patent and Trademark Office
127. FDA-2015-M-2100-0001Premarket Approval Response from FDA CDRH to Siemens Healthcare Diagnostics, Inc.
128. FDA-2014-N-0002-0025New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine…
129. FDA-2010-S-0664-186021st Century HealthCare, Inc. - OcuHealth Full Spectrum Formula - Maintain Eye Health
130. FDA-2014-S-0024-0016Traditional Medicinals Green Tea Peppermint Letter
131. FDA-2023-N-3902-0501Comment from Marla Carlson
132. FDA-2016-H-1480-0001Complaint
133. FDA-1991-E-0018-0007Determination of Regulatory Review Period for Purposes of Patent Extension for Certain…
134. FDA-2014-S-0024-0813Natural Factors Nutritional Products LTD (CherryRich Super Strength 500mg) - Letter
135. FDA-2016-H-1082-0001CTP CMP Case re Jai Ambee Petro Inc. d/b/a Quik Mart
136. FDA-2020-E-1818-0005Letter from FDA CDER to U S Patent and Trademark Office
137. FDA-2019-H-0190-0001Complaint
138. FDA-1978-N-0018-0863Reference 21 - FDA Guidance_2015_Nonclinical Evaluation of Endocrine-Related Drug Toxicity
139. FDA-2023-N-3902-1675Comment from Jeffrey Coy
140. FDA-1997-S-0039-0529BioEnergy Nutrients (Rememberine) LET966 - Letter
141. FDA-2021-S-0024-12332020-4315 The Carter-Reed Company - Relacore Total Sleep Cycle - support sleep quality…
142. FDA-2022-E-2192-0004Letter from U.S. Patent and Trademark Office to FDA CDER
143. FDA-2009-E-0174-0004U.S. Patent and Trademark Office to FDA/CDER
144. FDA-2007-P-0005-0002Acknowledgement Letter from FDA DDM to Association of Medical Device Reprocessors
145. FDA-2017-H-4611-0001CMP Complaint Issued to Smokestack Discount Tobacco, Inc. d/b/a Smoker Friendly Express…
146. FDA-2016-V-1154-0003Variance Amendment request
147. FDA-2017-H-3389-0001CMP Complaint Issued to Torres Superettes, Inc. d/b/a Torres Superettes Inc.
148. FDA-2024-S-0024-01092024-000592 - Nordic Naturals - Nordic Naturals Men's Multivitamin Extra Strength- support…
149. FDA-1997-F-0050-0001Eastman Chemical Co.; Filing of Food Additive Petition
150. FDA-2021-E-0029-0008Letter from FDA CDER to U.S. Patent and Trademark Office
151. FDA-1976-N-0031-0226Amendment from Vick's Division of Research and Development re Supplement 11 from Vick's…
152. FDA-2012-S-1144-0397Indiana Botanic Choice Inc - Sugar Equilibrium II - Encourages healthy carbohydrate and…
153. FDA-2015-P-0059-0001Acknowledgement Letter from FDA DDM to CSPI
154. FDA-2023-H-2166-0001Complaint
155. FDA-2021-V-1291-0001Variance Application from Automated Living Inc.
156. FDA-2007-P-0247-0007Citizen Petition from Regulus Pharmaceutical Consulting, Inc.
157. FDA-2018-S-0024-08592018001889- Mason Vitamins, Inc.- Mason Natural Vitamin B12- Support Conversion of Food…
158. FDA-2015-H-4274-0001CTP CMP Case re Marouf Investment LLC d/b/a Ayesh Food Mart
159. FDA-2011-S-0932-2241ProCaps Laboratories - Men's Life RX - Andrew Lessman Founder's - powerful protection to…
160. FDA-2015-D-3327-0001E6(R2) Good Clinical Practice; International Conference on Harmonisation; Draft Guidance…
161. FDA-2024-V-2079-0002Acknowledgment Letter from FDA DMS to Melodisc Ltd / Queensrazche
162. FDA-2020-V-0379-0002Acknowledgment Letter from FDA DMS to Technosolutionism, LLC
163. FDA-2011-N-0400-0007Approaches To Reducing Sodium Consumption; Public Meeting
164. FDA-2013-P-1516-0001Spectron mrc, LLC - Citizen Petition
165. FDA-2018-H-0820-0001Complaint
166. FDA-2023-D-5430-0001Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic…
167. FDA-2021-P-1310-0001Citizen Petition from Morehouse School of Medicine
168. FDA-2003-N-0161-0019Attachment 8 - "Strategic Action Plan, FDA Protecting and Advancing America's Health…
169. FDA-2019-D-3805-0075The Accreditation Scheme for Conformity Assessment (ASCA) Program Guidance for Industry…
170. FDA-2016-H-1010-0002Complaint
171. FDA-2020-E-2336-0003Patent Term Extension letter from FDA CDER to Honorable Drew Hirshfeld
172. FDA-2015-H-4799-0001CTP CMP Case re Supneet Fuel, LLC d/b/a Lansdale Food Mart and Deli
173. FDA-2024-E-3575-0004Letter from U.S. Patent and Trademark Office to FDA CDER
174. FDA-2012-P-1007-0002Acknowledgement Letter to Public Citizen
175. FDA-2018-P-1197-0004Response Letter from FDA CDER to Exela Pharma Sciences
176. FDA-2010-N-0600-0002Agency Information Collection Activities; Proposals, Submissions, and Approvals: Animal…
177. FDA-2021-P-1334-0011Tab 9 - REGENXBIO Application for Extension of Patent Term re: Citizen Petition from Hogan…
178. FDA-2021-P-1081-0007Withdrawal from Hyman, Phelps & McNamara, P.C.
179. FDA-2018-H-4538-0001Complaint
180. FDA-2024-N-5471-0574Reference 572 Travis Cancer survivorship genetic 2006
181. FDA-2006-E-0434-0008Wyeth Holdings Corporation - Patent Term Extension Application
182. FDA-1990-S-0006-0226HFD-7 - Memo - 12/2/1997
183. FDA-1997-S-0039-1232Perrigo - Multiple claims - 9
184. FDA-2020-N-2029-0318Final Closing Summary RE Hearing Involving the Obstetrics, Reproductive and Urologic Drugs…
185. FDA-1991-N-0365-0144Answer from FDA/DDM to Honorable Mike McKevitt Re: Comment from Colorado Veterinary…
186. FDA-2013-V-0560-0003FDA/CDRH to Ryan Richards - Approval for Variance
187. FDA-2011-S-0932-2399Perrigo Company of South Carolina - Vitasmart - Estroplus - Helps reduce hot flashes &…
188. FDA-1999-N-0035-0001Jay Marcus; Proposal to Debar; Opportunity for a Hearing
189. FDA-1982-N-0005-0044Comments on the Tentative Final Monograph for Orally Administered Drug Products for Relief…
190. FDA-2018-H-0509-0001Complaint
191. FDA-2025-P-3130-0014Attachment 12 - FDA v. Alliance - Joint Appendix Volume 2
192. FDA-2014-H-1157-0001Complaint
193. FDA-2023-H-1129-0001Complaint
194. FDA-2015-V-0606-0003Variance Approval from FDA CDRH to MASTER DISPLAYS LIMITED
195. FDA-2001-C-0209-0001FDA
196. FDA-2022-S-0024-13632022-001928 - TSI USA LLC - Tailored Script, Boswellia - Supports key enzymes involved in…
197. FDA-1997-V-0018-0007Paramount Organization Inc. dba Paramount Event Services, Inc. - Request for Extension of…
198. FDA-2023-E-3227-0005Requirement for Information Pursuant to 37 C.F.R. 1.750
199. FDA-2024-E-0218-0004Patent Term Extension for Application from Phathom Pharmaceuticals, Inc. ( Triple Pak) (on…
200. FDA-1996-V-0026-0002N Effect Production - Application for Variance
201. FDA-2024-H-1736-0001Complaint
202. FDA-1999-P-4073-0003Attachment B Proposed Labeling for Propoxyphene Napsylate and Acetaminophen…
203. FDA-2014-D-1351-0002Flow Cytometric Devices; Draft Guidance for Industry and Food and Drug Administration…
204. FDA-1979-P-0027-0002Withdrawal of Certain Proposed Rules and Other Proposed Actions; Notice of Intent
205. FDA-2018-V-0364-0001Variance Application from Dexstrumental
206. FDA-2003-V-0418-0002HFZ-300 to Discovery Beach Restaurant & Club, Inc.
207. FDA-2019-N-3723-0005REF 3 - 08.09.11 Letter to Watson re Letter from FDA CDER to Watson Laboratories re…
208. FDA-1980-N-0038-0255Disclosure of Data and Information from Ciba-Geigy Corporation (Vol. 10 of 12)
209. FDA-2020-S-0024-02572020-000347 International Vitamin Corporation- MULTIPLE CLAIMS (3)
210. FDA-2004-P-0210-0003Acknowledgement Letter from FDA DMB to Center for Science in the Public Interest
211. FDA-2018-N-3552-0004002 - Reference 1 - Murphy et al - Deaths Final Data for 2010
212. FDA-1977-N-0014-0962Answer Letter from FDA to Comment from The Honorable Thomas F. Eagleton, United States…
213. FDA-2025-P-1097-0002Acknowledgment Letter from FDA DMB to Fresenius Kabi USA, LLC
214. FDA-2023-H-0130-0001Complaint
215. FDA-2007-D-0369-0897PSG_213137 Draft Guidance on Voxelotor
216. FDA-2017-H-4384-0001CMP Complaint Issued to Yin Liu d/b/a Dollar City and Asian Food Mart
217. FDA-2004-N-0380-0004Supporting Statement for Reports of Corrections and Removals
218. FDA-2016-S-0024-2092NBTY Inc - Aloe Vera Gel supplements - Aloe Vera Gel is a source of plant nutrients that…
219. FDA-2020-P-1443-0006Tab 3 Re: Citizen Petition from Elanco Animal Health
220. FDA-2019-S-0024-10412019-002839 International Vitamin Corporation- MULTIPLE CLAIMS (10)
221. FDA-2005-P-0004-0012State of Connecticut
222. FDA-2022-P-2644-0009Attachment 7 FDA 2014 2015 Strategic Priorities re Reclassification Petition from Karl…
223. FDA-2022-S-0023-0005NDI 1236 - Serratiopeptidase from Meteoric Biopharmaceuticals Pvt. Ltd.
224. FDA-2009-M-0299-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premaket Approval…
225. FDA-2020-S-0024-00122020-000012 Jarrow Formulas, Inc- Jarro-Dophilus Baby- Supports the colonization of an…
226. FDA-2024-H-1138-0001Complaint
227. FDA-2019-H-0062-0001Complaint
228. FDA-2020-H-0827-0001Complaint
229. FDA-2010-S-0664-1184EuroPharma, Inc. - Curamin - Relief for Occasional Muscle Pain Due to Exercise or Overuse
230. FDA-2014-N-0229-0003Issuance of Priority Review Voucher; Rare Pediatric Disease Product
231. FDA-2020-H-1240-0001Complaint
232. FDA-2014-N-0189-35563Request for Extension from Anonymous
233. FDA-2024-H-2491-0001Complaint
234. FDA-2010-S-0664-1970Perrigo - Good Neighbor Pharmacy C - Essential for Healthy Bones, Gums and Blood Vessels
235. FDA-2011-S-0932-2445NBTY, Inc. - Olive Leaf Extract - Nutritionally Supports Overall health
236. FDA-2023-H-0521-0001Complaint
237. FDA-1986-P-0035-0009Supplement from Abbott Laboratories (Clifford & Warnke)
238. FDA-2014-N-1051-0643643 7694105 Survey Subject R2017_Redacted
239. FDA-2004-S-0304-0002Background Material
240. FDA-2022-H-1427-0001Complaint
241. FDA-1997-S-0006-1528Courtesy letter and related material from CFSAN to Bio Extracts
242. FDA-1975-N-0012-0499Appendix 1 EPAs Toxicology Evaluation of Benzalkonium Chloride re Comment from Lonza Inc…
243. FDA-2008-E-0267-0010United States Patent and Trademark Office - Letter With Attached Certificate
244. FDA-2023-S-0024-07622023-001813 - CanPrev Natural Health Products Ltd. - D3 & K2 (Softgels 120) - Supports…
245. FDA-1979-P-0020-0001Variance Approval Letter from FDA CDRH to Brevard Community College Astronaut Memorial…
246. FDA-2014-D-0622-0002Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs
247. FDA-2006-V-0293-0002FDA / DDM to Electric Cowboy
248. FDA-2018-H-2586-0001Complaint
249. FDA-2015-P-5022-0004Exhibit B Industry Standard Research's ASBM Labeling Survey re Citizen Petition from…
250. FDA-2022-N-2390-0395Exhibit 74 - Coren Percept Motor Skills (1996)
251. FDA-1982-N-0046-0005Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered…
252. FDA-2022-H-3018-0001Complaint
253. FDA-2006-E-0261-0003FDA/CDER to the USPTO - Letter
254. FDA-2024-H-4741-0001Complaint
255. FDA-1996-P-0100-0004Interim Response Letter from FDA CFSAN to Cancer Prevention Coalition et al
256. FDA-2017-H-3914-0001CMP Complaint Issued to Tejspann LLC d/b/a Superway
257. FDA-2016-E-1179-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
258. FDA-2018-H-3703-0001Complaint
259. FDA-1980-N-0049-0134Background Information re Biological Products; Bacterial Vaccines and Toxiods…
260. FDA-2022-N-2688-0001NOOH Letter from FDA ORA to Analay Rico
261. FDA-1981-F-0008-0002Toray Industries, Inc.; Filing of Food Additive Petition
262. FDA-1977-N-0002-1256Answer Letter from FDA/Office of Legislative Services to Honorable J. Kenneth Robinson…
263. FDA-1996-N-0234-0001Review of the Calcium and Related Nutrient Needs of the U.S. Population; Announcement of…
264. FDA-2010-N-0564-0003Agency Information Collection Activities; Proposals, Submissions, and Approvals…
265. FDA-2014-V-0828-0001Variance Application from Laser Production Network on behalf of KNR Wall Lounge
266. FDA-2024-V-1503-0003Variance Approval Letter from FDA CDRH to Mark Garetz
267. FDA-2005-P-0055-0005Citizen Petition Partial Approval and Denial Response from FDA CDER to Rosei Rocha-Judd
268. FDA-2025-S-0024-06652025-000757 - CanPrev Natural Health Products Ltd. - Vitamin D3 2500IU Drops - maintain…
269. FDA-2023-E-2460-0002Patent Extension Application from Bristol-Myers Squibb Company
270. FDA-2011-D-0436-0026International Conference on Harmonisation; Guidance Availability: Q11 Development and…
271. FDA-2020-S-0024-02782020-000373 Lang Pharma Nutrition, Inc- CVS Live Better Saw Palmetto Extract- Supports…
272. FDA-2006-N-0040-0093Reference 77-6 Public Conference July 17 2012 Secondary Bacterial Screening of Platelet…
273. FDA-2015-H-4180-0001CTP CMP Case re Dalia Management, LLC d/b/a Ann’s Market / Pop’s Market
274. FDA-1984-G-0007-0220Background Material: E-6 Report Evaluation of Hydrogenated Starch Hydrolysate and High…
275. FDA-2014-H-2270-0001Complaint
276. FDA-2014-N-0998-0005Agency Information Collection Activities; Submission for Office of Management and Budget…
277. FDA-2023-V-4393-0002Acknowledgment Letter from FDA DMS to EOTECH LLC
278. FDA-1980-N-0067-0035Reference 20 re: Public Administrative File for Over-the-Counter Vaginal Contraceptive…
279. FDA-2023-V-3390-0002Acknowledgment Letter from FDA DMS to Seiko Epson Corporation
280. FDA-2021-V-1138-0001Variance Application from Laurence Hall
281. FDA-2017-H-5099-0001Complaint
282. FDA-2016-S-0024-2329Natural Factors Nutritional Products Inc. - Garcinia Cambogia 750 mg capsules - Healthy…
283. FDA-1976-N-0476-0452Answer Letter from FDA to EG&G Mason Research Institute
284. FDA-2023-H-1724-0001Complaint
285. FDA-2010-N-0488-0008Reference 13 - Centers for Disease Control and Prevention, "Cigarette Use Among High…
286. FDA-1997-S-0006-0916HFS-810 to Market America Inc. - Letter - Let 592
287. FDA-2017-S-0024-0110NOHO Health Inc. dba Care/Of 1, Ashwagandha, relieving occasional stress, strength…
288. FDA-2022-H-2642-0001Complaint
289. FDA-2017-V-0343-0001Variance Application from Light It Up Events LLC
290. FDA-2025-H-4623-0001Complaint
291. FDA-2012-P-0760-0001Purdue Pharma L.P., (Kleinfeld, Kaplan and Becker, LLP) - Citizen Petition
292. FDA-1991-N-0025-0022BACKGROUND MATERIAL
293. FDA-2010-P-0255-0008Exhibit E- "Clinical Pharmacology and Biopharmaceutics Review(S), 22-104" - [Sun…
294. FDA-2014-H-1250-0002Complaint
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302. FDA-2025-S-0024-11212025-001211 - Prestige Consumer Healthcare - Advanced Herbals, Non-Drowsy Ginger - Motion…
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351. FDA-2013-N-0134-0187Agency Information Collection Activities; Proposed Collection; Comment Request…
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353. FDA-2025-P-1068-0003Interim Response
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355. FDA-1982-N-0011-0110Background Material
356. FDA-2023-S-0024-01512023-000186 - Proton Health - Alegon - Product accelerates the metabolism of alcohol by…
357. FDA-1997-S-0039-2719Perrigo - HEALTHsense - Ginkgo Biloba - Improves memory & concentration
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379. FDA-2022-S-0024-14622022-002018 - Pharmavite LLC - 1 - Nature Made Melatonin 3 mg Tablets - Supports a healthy…
380. FDA-1987-P-0374-0003Exhibit B Approved Labeling Hyperstat I.V. Injection re: Citizen Petition from LyphoMed…
381. FDA-2016-H-0418-0002Complaint
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385. FDA-2025-P-1096-0003Attachment 1 - Pioneer Product Label
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387. FDA-2014-S-0023-0044Background Material re NDI 827 - L-Theanine from Sato Pharmaceutical Co., Ltd
388. FDA-2016-N-0832-0033Exhibit 10 Declaration of Kevin Bynum re: Request for Hearing from Phibro Animal Health…
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391. FDA-2018-C-4464-0006Correspondence related to codified
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395. FDA-2016-H-1845-0001Complaint
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397. FDA-2018-H-1822-0001Complaint
398. FDA-2013-H-1238-0001Complaint
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406. FDA-2011-S-0932-2256Waterpure, Inc. d/b/a Purity Products - KrillBerry - Heart, Joint, Brain and Energy…
407. FDA-2011-S-0932-2725LA Weight Loss, LLC - LA MetaBoost 6 , LA VitaBoost 12, LA VitaFemme, LA Snackbuster, LA…
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417. FDA-1991-N-0043-0001FDA
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424. FDA-2015-N-3469-0186Nomination from Outsourcing Facilities Association
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426. FDA-2010-N-0548-0096Reference 7 - OECD Series on Principles of GLP and Compliance Monitoring Number 4…
427. FDA-2025-S-0024-08002025-000900 - Plexus Worldwide LLC- Plexus, Restore - Supports liver function to naturally…
428. FDA-2007-D-0150-0001Draft Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Studies…
429. FDA-1980-N-0038-0495Order Amending the Schedule for Cross-Examination
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463. FDA-2010-N-0155-0007Academy of Veterinary Consultants (AVC) - Request for Extension of Comment Due Date
464. FDA-2019-D-5404-0002Mucopolysaccharidosis Type III(Sanfilippo Syndrome): Developing Drugs for Treatment…
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471. FDA-2002-N-0313-0003Agency Information Collection Activities; Proposed Collection; Comment Request…
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474. FDA-2015-H-1295-0001Complaint
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516. FDA-2007-D-0369-0530PSG_205613 - Draft Guidance on Budesonide
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554. FDA-2016-S-0024-23892016000597-Flora, Inc - Floradix Iron Tablets Supplement - Helps to maintain healthy iron…
555. FDA-2015-S-0024-0063FitLifeBrands Inc - BCAA Charged - Support for antioxidant
556. FDA-2014-D-1849-0004Medical Devices and Clinical Trial Design for the Treatment or Improvement in the…
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558. FDA-2004-N-0503-0003Agency Information Collection Activities; Submission for Office of Management and Budget…
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578. FDA-2019-H-3000-0001Complaint
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580. FDA-2010-S-0664-0387Roex, Inc. - Roex Chewable Probiotics - Supports the Favorable Balance of Intestinal…
581. FDA-2018-P-2985-0006Amendment to Citizen Petition from Norbrook Inc.
582. FDA-2019-N-3077-0004Agency Information Collection Activities; Submission for Office of Management and Budget…
583. FDA-2018-D-2614-0002Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form…
584. FDA-2017-H-3255-0001CMP Complaint Issued to Sullivan Enterprises LLC d/b/a Sullivan’s Market
585. FDA-2023-H-0410-0001Complaint
586. FDA-2015-H-0044-0001Complaint
587. FDA-2024-S-0024-08492024-001721 - Herbalife - AM Renew Formula - support liver
588. FDA-2023-E-3266-0002Patent Extension Application from GSK Intellectual Property Department (on behalf of…
589. FDA-2024-V-3161-0001Variance Application from Whole New World Productions
590. FDA-2021-V-1170-0001Variance Application from Blt Nightlife, LLC
591. FDA-2018-H-2276-0001Complaint
592. FDA-2018-P-1949-0034Fn 38_NCT01262456 ClinicalTrials_gov re Citizen Petition from Avadel Specialty…
593. FDA-1975-N-0017-0007Letter from FDA/CDER to Bristol-Myers Products
594. FDA-2019-H-2019-0001Complaint
595. FDA-2020-P-0945-0013Interim Response letter from FDA CDRH to Dr. Ernest C. Chisena and Dr. Jahangir S…
596. FDA-2010-S-0664-1393Source Naturals - Calcium Hydroxyapatite - Keep Bones Healthy and Strong
597. FDA-2004-D-0371-0002Guidance
598. FDA-2023-E-2806-0005Letter from U.S. Patent and Trademark Office to FDA CDER
599. FDA-1997-S-0006-0576Metabolic Technologies Inc., LET285 Response From FDA/CFSAN - Courtesy Letter
600. FDA-1981-F-0034-0001Witco Chemical Corp.; Filing of Food Additive Petition
601. FDA-2015-N-3037-00340030_R_IND79010_A0027_Status2_CSR_16-1-1_Protocol-and-Amendments
602. FDA-2014-S-0024-1142Eclectic Institute (Calming Tonic) - Letter
603. FDA-2025-P-1277-0008Response Letter
604. FDA-2022-H-2537-0001Complaint
605. FDA-2006-D-0302-0002Guidance
606. FDA-2015-S-0024-2658NBTY - Chelated Zinc supplements - Supports immune, skin and antioxidant health
607. FDA-2020-V-1852-0001Acknowledgment Letter from FDA DMS to Jonah Dotan
608. FDA-2007-D-0369-2299PSG_018662 - Draft Guidance on Isotretinoin
609. FDA-2005-D-0140-0021Reference 10 Blood Products Advisory Committee, 69th Meeting, June 14, 2001
610. FDA-2024-H-4358-0001Complaint
611. FDA-1992-N-0049-0019Background Material
612. FDA-2013-S-0024-0919Yintang Therapeutics, LLC - Core Vitality - For general wellness and improved energy
613. FDA-2005-N-0297-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of…
614. FDA-2024-N-3481-0001Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2025
615. FDA-2018-H-1799-0001Complaint
616. FDA-2023-N-3902-0362Comment from Laura Walker
617. FDA-1977-N-0002-0830Envelope re: Comment from Honorable Sam Nunn, United States Senate
618. FDA-1999-N-0095-0002Agency Information Collection Activities; Submission for OMB Review; Comment Request; Food…
619. FDA-2021-P-0376-0003Withdrawal from Braintree
620. FDA-2024-H-3688-0001Complaint
621. FDA-2016-H-0323-0001CTP CMP Case re Mulligan Holdings, LLC d/b/a Jugtown Country Store
622. FDA-2016-E-2514-0002Letter from U.S. Patent and Trademark Office
623. FDA-2013-D-0920-0002Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for…
624. FDA-2024-V-0257-0002Acknowledgment Letter from FDA DMS to Pro Audio
625. FDA-2017-V-2427-0002Acknowledgement Letter from FDA DDM to Christopher Short
626. FDA-1999-D-0030-0003Guidance for Industry INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and…
627. FDA-2011-S-0932-0398Letter from NBTY, Inc.
628. FDA-2013-V-0548-0003FDA/CDER to Lasertek Corporation - Approval for Variance
629. FDA-2015-S-0024-0732Perrigo Company of South Carolina - Health Mart® - E - Supports Heart Health
630. FDA-2009-D-0268-0005Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of…
631. FDA-2022-V-1079-0002Acknowledgment Letter from FDA DMS to Craig Stoddard
632. FDA-2004-P-0024-0001Acknowledgment Letter from FDA DMB to Bioniche Animal Health USA, Inc.
633. FDA-2015-N-0002-0039FREEDOM OF INFORMATION SUMMARY NADA 141-438 KAVAULT Avilamycin Type A Medicated Article…
634. FDA-1995-S-0036-0037Baxter INDA#6859
635. FDA-2004-P-0013-0006Letter from FDA CDER to Hikma Farmaceutica (Portugal), Lda (DUPLICATE)
636. FDA-2024-V-1306-0002Acknowledgment Letter from FDA DMS to Kevin Pham
637. FDA-2019-H-0407-0001Complaint
638. FDA-2019-H-0865-0001Complaint
639. FDA-2023-V-5535-0001Variance Application from Crystal Bay Club Casino
640. FDA-1996-P-0016-0021Background Material
641. FDA-2004-N-0037-0010FDA Confirmation Letter of Review Framework for Piroctone Olamine to Keller and Heckman…
642. FDA-2019-N-1482-4341Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived…
643. FDA-2025-E-1678-0003Letter to U. S. Patent and Trademark Office
644. FDA-2021-E-0380-0005Letter from FDA CDER to U.S. Patent and Trademark Office
645. FDA-2004-V-0487-0003Variance Approval from FDA CDRH to Clark Planetarium
646. FDA-2015-P-0732-0055[TAB 51] Schnitzer et al., Preferential interaction of albumin-binding proteins, gp30 and…
647. FDA-2019-H-5086-0001Complaint
648. FDA-2014-N-0189-3484Request for Extension from Anonymous
649. FDA-2013-S-0024-0646ProCaps Laboratories - Ultimate Whey Protein Isolate - Whey Protein is a dairy-based…
650. FDA-2015-P-1898-0003Determination That KYTRIL Granisetron Hydrochloride) Tablets, Equivalent 1 Milligram and 2…
651. FDA-2006-P-0204-0003FDA/CDER to Boehringer Ingelheim Pharmaceuticalws Inc
652. FDA-2011-E-0014-0001Amgen, Inc. - Patent Term Extension Application
653. FDA-2011-V-0201-0003Light Show Annual Report
654. FDA-2016-S-0024-1774NBTY - Melatonin supplements - For occasional sleeplessness
655. FDA-2009-P-0362-0004Attachment 2 - Rokicki, Nitinol Surface Inclusions Detection: the Primary Fatigue…
656. FDA-2025-H-7181-0001Complaint
657. FDA-2014-S-0024-0613Herbtheory (Postnatal Slim) - Letter
658. FDA-2023-H-5025-0001Complaint
659. FDA-2018-N-1988-0002Letter from Kohrman Jackson Krantz (KJK) to FDA DDM
660. FDA-2000-N-0190-0022Reference 4 - "The Value of Consumer Loss to Foodborne Reactive Arthritis (63 FR 24253…
661. FDA-2016-F-0821-0005Reference 3 Memorandum from Y. Zang, Division of Petition Review, Toxicology Review Team…
662. FDA-1974-P-0010-0002Pt. 8.501 Extension of the Expiration Date for Current Provisionally Listed Colors…
663. FDA-2016-E-2514-0005Determination of Regulatory Review Period for Purposes of Patent Extension; PROACT…
664. FDA-2025-H-2025-0001Complaint
665. FDA-2025-S-0024-03092025-000390 - Fungi Perfecti LLC - Host Defense Mushrooms, Stamet's7 Gummies - Daily…
666. FDA-2019-S-0024-08712019-002600 - i-Health, Inc. - Culturelle Kids Probiotic Gummies - Supports a healthy…
667. FDA-1989-V-0011-0002Variance Application from U.S. Department of Interior, Bureau of Reclamation
668. FDA-2018-E-0705-0004Letter from FDA CDER to U.S. Patent and Trademark Office
669. FDA-2000-S-1575-0042NDI 71 - Acicarpha tribuloides from Isula Rain, Inc.
670. FDA-2012-S-1144-0694NBTY, Inc. - Clacium + D - Helps Maintain Bone Health
671. FDA-2016-N-3120-0024redacted_008 Meeting Minutes
672. FDA-1977-N-0014-1205Answer from FDA to Comment from Lucas Products Company
673. FDA-1993-P-0169-0002Acknowledgment Letter from FDA DDM to Scott G. Beach
674. FDA-2025-E-3618-0004Letter from U.S. Patent and Trademark Office to FDA CDER
675. FDA-2009-S-0607-1126Perrigo - Equaline Daily Prenatal Combo Pack - DHA Helps Support Healthy Fetal Brain and…
676. FDA-2020-N-2029-0330Covis.Makena.August.26.2022.Letter RE Proposal to Withdraw Marketing Approval; Notice of…
677. FDA-2014-E-0271-0005Letter from FDA CDER to the U.S. Patent and Trademark Office
678. FDA-2023-H-5404-0001Complaint
679. FDA-2008-N-0281-0027PDUFA Pilot Project - Proprietary Name Review - Concept Paper - September 2008
680. FDA-1997-S-0006-1429Courtesy Letter from CFSAN to i-Health, Inc.
681. FDA-2021-S-0024-12992021-1313 Bluebonnet Nutrition Corporation-1-Bluebonnet's Ladies' ONE Prenatal Vegetable…
682. FDA-2009-P-0235-0003FDA/CDER to Kleinfeld, Kaplan and Becker, LLP - Petition Partial Approval and Denial
683. FDA-2016-V-1087-0001Variance Application from R5 Entertainment LLC
684. FDA-2007-D-0369-1799PSG_019955 - Draft Guidance on Desmopressin Acetate
685. FDA-2016-S-0024-0836Platinum Naturals Inc. - activ-X™ for Women - Gives you more energy, boost stamina and…
686. FDA-2023-S-0024-00422023-000050 - FitLife Brands Inc - PMD, Z Test - Support for testosterone, boosting growth…
687. FDA-1997-S-0006-0904HFS-810 to Shanti Herbs - Letter - Let 586
688. FDA-2008-P-0542-0003Attachment 11 - "Toxicology of Rebaudioside A:A Review" - [Coburn & Coffman PLLC - Citizen…
689. FDA-2019-S-0024-03422019002332 - Unipharma LLC - Dr.Kids Natural Cough Syrup / Ivy Leaf - Soothes occasional…
690. FDA-2005-P-0316-0003Letter from FDA CDER to Skadden, Arps, Slate, Meagher & Flom LLP
691. FDA-2023-N-3902-0227Attachment 12 Letter from FDA CDRH to St. Jude Medical, Inc. re: Supplemental Comment from…
692. FDA-2016-D-0199-0027Enforcement Policy Regarding Use of National Health Related Item Code and National Drug…
693. FDA-2018-H-0104-0001Complaint
694. FDA-2025-S-0024-12642025-001356 - Healthy Decisions Inc. - SimpWel - Supports overall immune resilience in…
695. FDA-2016-P-2955-0088Response from FDA CBER to Nicholas Isel_Redacted
696. FDA-1978-N-0018-0333FDA
697. FDA-2004-V-0172-0003HFZ-300 to HB Stereo Inc
698. FDA-2014-N-0189-6769Request for Extension from Tony Colona
699. FDA-2024-P-0667-0004Attachment 2 - Prescribing Information for RLD Magnesium Sulfate in Water for Injection…
700. FDA-2015-S-0024-3481NOW - NATTOKINASE 100 mg - Helps Maintain Normal Blood Flow
701. FDA-2015-S-0024-3180Perrigo - Factory OTC®- promotional - Supports immune & bone health
702. FDA-2022-S-0024-10552022-001102 - CEDEM AG Switzerland - VitaCed Keto effervescent Tablet - Supports normal…
703. FDA-2012-V-1156-0002Acknowledgement Letter to Thunderstorm Mobile Audio
704. FDA-2006-N-0178-0046Tab 1 - FDA Center for Devices and Radiological Health - Background Material
705. FDA-2020-V-2243-0002Acknowledgment Letter from FDA DMS to Duke Garlin
706. FDA-2015-D-3787-0015Electromagnetic Compatibility of Medical Devices; Draft Guidance for Industry and Food and…
707. FDA-2013-H-1118-0001Complaint
708. FDA-2016-V-2517-0005Approval letter for FDA CDRH to Wi-Charge Ltd
709. FDA-2019-H-4170-0001Complaint
710. FDA-2001-P-0238-0005Letter from FDA CDER to Lachman Consultant Services, Inc. - Letter
711. FDA-2019-D-4964-0006Request for Extension from Biotechnology Innovation Organization (BIO)
712. FDA-2000-P-1381-0002Acknowledgement Letter from FDA DMB to Yamanouchi Pharma Technologies, Inc.
713. FDA-2013-S-0024-1057Perrigo - Equaline® - Biotin -Helps support healthy hair and skin
714. FDA-2024-H-1968-0001Complaint
715. FDA-1989-G-0391-0125References: Articles and Publications (Abstracts and Authors with Letter C 2 of 3 ) re…
716. FDA-2004-H-0391-0098FDA/DDM
717. FDA-2018-D-1752-0028Public Availability of Lists of Retail Consignees To Effectuate Certain Human and Animal…
718. FDA-2015-M-3256-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
719. FDA-1977-N-0002-0893Letter from Honorable David C. Treen, House of Representatives to Robert C. Wetherell…
720. FDA-2014-V-0394-0006Variance Approval from FDA CDRH to The Likquid Project
721. FDA-2014-N-0189-6981Request for Extension from Anonymous
722. FDA-2015-S-0024-2050Perrigo - Walgreens - Glucosamine Chondroitin - Boron - Helps support bone health
723. FDA-2023-H-4791-0001Complaint
724. FDA-2016-M-2652-0001Premarket Approval Response from FDA CDRH to BIOTRONIK, Inc. PRO-Kinetic Energy Cobalt…
725. FDA-2017-H-0905-0001CMP Complaint Issued to Redner’s Markets, Inc. d/b/a Redner’s Warehouse Markets
726. FDA-2013-D-0576-0031Reference 11 Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events…
727. FDA-2018-E-4415-0002Patent Extension Application from Tina M. Tucker (on behalf of Eli Lily and Company)
728. FDA-2013-E-0785-0002U.S. Patent and Trademark Office - Letter
729. FDA-1997-N-0011-0001Notice of Final Rule re Human Cells, Tissues, and Cellular and Tissue-Based Products…
730. FDA-2009-V-0467-0003Variance Approval from FDA CDRH to L-3 Communications Wescam
731. FDA-2012-S-1144-2596NBTY, Inc. - Beta-Carotene - Supports Eye, Skin, Immune & Antioxidant Health
732. FDA-2025-S-0024-02222025-000302 - Life Science Nutritionals - Spring Valley, Kid's Probiotic with Prebiotic…
733. FDA-2018-H-4821-0001Complaint
734. FDA-2024-P-4890-0008Completeness Assessment Correspondence
735. FDA-2023-N-0249-0002Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak…
736. FDA-2013-N-0227-0239Reference 170 Carter Product Standards Raw Material Contamination 1988
737. FDA-2008-C-0098-0003Listing of Color Additives Exempt From Certification: Bismuth Citrate
738. FDA-1995-N-0054-13553Background Material for NFR 1
739. FDA-2023-P-2347-0003Attachment 1 Galliprant grapiprant Tablets re Suitability Petition from Aurora…
740. FDA-1997-S-0039-2526Perrigo Company of South Carolina - equate - Calcium Citrate+D - Supports Bone Health
741. FDA-2007-D-0027-0002Guidance
742. FDA-2010-S-0664-1649NOW Foods - Protocol for Life Balance ProtoDophilus - Digestive Support
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744. FDA-2025-S-0024-07862025-000886 - Plexus Worldwide LLC - Plexus IronWoman - Helps alleviate iron deficiency…
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746. FDA-2018-N-0180-0003Agency Information Collection Activities; Submission for Office of Management and Budget…
747. FDA-2015-S-0024-3131Country Life - Dairy-Zyme - Aids in digestion of dairy
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750. FDA-2017-H-2986-0001CMP Complaint Issued to Narayan, Inc. d/b/a Shoppers Vineyard Discount Wine and Spirits
751. FDA-1992-P-0120-0001Citizen Petition from Angela Cassady
752. FDA-2020-E-2364-0004Letter from FDA CDER to U.S, Patent and Trademark Office
753. FDA-2016-H-4480-0001Complaint
754. FDA-2009-S-0608-0163NDI 618 - Sea Buckthorn Berry Juice - Original NDI Notification
755. FDA-2024-S-0024-07552024-001599 - NATURAL TARGET LLC - Immune health
756. FDA-2014-D-1177-0001International Cooperation on Harmonisation of Technical Requirements for Registration of…
757. FDA-1999-M-0103-0001Medical Devices; Availability of Safety and Effectiveness Summaries for PMA
758. FDA-2002-P-0123-0013TAB 5- The Pediatric Infectious Disease Journal
759. FDA-2023-P-5687-0001Citizen Petition from Bionpharma, Inc.
760. FDA-2011-N-0110-0001Memorandums of Understandings; Extensions: Entry of Mexican Cantaloupes into United States…
761. FDA-2018-S-0023-0156NDI 1100 - 5-hydroxy-L-tryptophan (5-HTP) - Original NDI Notification
762. FDA-2019-V-1797-0002Acknowledgment Letter from FDA DDM to Lawrence Dickey
763. FDA-2023-P-2267-0003Final Response from FDA ORA to Harry Duty
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765. FDA-2026-P-0028-0005Appendix C - Neurology
766. FDA-2015-H-4453-0001CTP CMP Case re Platte Valley Foods, LLC d/b/a Valley Foods and Liquor
767. FDA-2006-P-0211-0002Acknowledgment Letter from FDA DDM to QPharma, LLC
768. FDA-2019-V-1291-0003Acknowledgement Letter from FDA DDM to August Burns Red
769. FDA-2021-S-0024-05662021-000888 - Laird Superfood- Laird Superfood Renew: Rest & Recover- maintaining normal…
770. FDA-2001-P-0369-0002Citizen Petition Denial from FDA CDER to Morgan, Lewis & Bockius, LLP on behalf of Pfizer…
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773. FDA-2023-H-0602-0001Complaint
774. FDA-1996-P-0016-0017Background Material
775. FDA-2010-P-0082-0003Exhibit 1- "Polymer-Coated Technology: Health Professionals (January 2008)" - [Actavis…
776. FDA-2016-S-0024-1539Covaxil Laboratories - NuraDyne™ dietary supplement - Dynamic neural activator
777. FDA-2010-P-0326-0004FDA/CDER to JRRapoza Associates, Inc. - Response Letter
778. FDA-2013-E-0400-0002U.S. Patent and Trademark Office - Letter
779. FDA-1975-N-0016-0017Memorandum of Telephone Conversation Between Mitech Laboratories, Inc. and FDA CDER
780. FDA-2012-S-1144-0490NOW - NOW® Inositol Hexaphosphate - Healthy Cell Growth and Reproduction
781. FDA-2013-N-0883-0001Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for OXYCONTIN
782. FDA-1997-S-0039-1949Enzymatic Therapy, Inc. - Liquid Calcium Magnesium - Keep bones strong and connective…
783. FDA-2011-S-0932-2150Pure Essence Labs, Inc. - Mother To Be - provides over 50% whole food nutrition (the best…
784. FDA-2022-H-1001-0001Complaint
785. FDA-2017-R-4512-0001NTSO Complaint Issued to B.P. Channelside, Inc. d/b/a Metro Marathon and Zelda’s Café
786. FDA-2019-H-1714-0001Complaint
787. FDA-2021-P-0438-0004Attachment 2- Per and Polyfluoroalkyl Substances (PFAS) FDA re: Citizen Petition from Joe…
788. FDA-2012-N-0001-0049Science Board to the Food and Drug Administration; Notice of Meeting
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790. FDA-2022-D-2059-0002Providing Over-the-Counter Monograph Submissions in Electronic Format; Guidance for…
791. FDA-2018-V-2378-0002Acknowledgment Letter from FDA DDM to Jeremy Buckingham
792. FDA-2024-P-5304-0003Determination That MOBIC (Meloxicam) Tablets, 7.5 Milligrams and 15 Milligrams, Were Not…
793. FDA-2014-N-0002-0012Environmental Assessment for Use of the EAZI-BREED™ CIDR Cattle Insert for Induction of…
794. FDA-2017-S-0024-06622017000811 - ONPOK - MULTIPLE CLAIMS (7)
795. FDA-1981-N-0013-0002FDA
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801. FDA-2015-V-1370-0002Acknowledgement Letter from FDA DDM to EMPIRE WHOLESALE
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803. FDA-2015-H-4909-0001CTP CMP Case re Currie’s Standard, Inc. d/b/a Curries / BP
804. FDA-2019-H-3455-0001Complaint
805. FDA-2016-V-3767-0002Acknowledgement Letter from FDA DDM to Hypnotic Productions
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808. FDA-1980-M-0168-0001Abbott Laboratories; Premarket Approval of Abbott-HBe Diagnostic Kit
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812. FDA-2016-H-3975-0001Complaint
813. FDA-2024-H-0084-0001Complaint
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816. FDA-2010-D-0281-0018Guidance for Industry for “Harmful and Potentially Harmful Constituents” in Tobacco…
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821. FDA-2025-N-1927-0005GRAS (GRN) Notice 1168 Part 1
822. FDA-2015-S-0024-0886Mountain Rose Herbs - Mountain Rose Herbs, Spring Care extract - Provides natural mucilage…
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825. FDA-2010-N-0268-0001Dental Products Panel of the Medical Devices Advisory Commeeting; Notice of Meeting
826. FDA-2016-S-0024-0339NBTY Inc - Natural Whey Protein Vanilla Flavored supplements - Fuels muscle recovery and…
827. FDA-2022-H-2495-0001Complaint
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830. FDA-2010-N-0256-0001Indexing Structured Product Labeling for Human Prescription Drug and Biological Products…
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838. FDA-2025-H-7254-0001Complaint
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846. FDA-2005-V-0077-0002Acknowledgement Letter to Club Element
847. FDA-2020-P-1052-0002Acknowledgment Letter from FDA DMS to National Tobacco Reform Initiative (NTRI)
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850. FDA-2017-H-5494-0001Complaint
851. FDA-2019-N-5611-0001Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the…
852. FDA-2019-H-1578-0001Complaint
853. FDA-2011-P-0337-0003Precision Nuclear, LLC - Amendment
854. FDA-2019-H-4312-0001Complaint
855. FDA-2015-E-0858-0008Letter from FDA CDER to U.S. Patent and Trademark Office
856. FDA-2015-E-0846-0001Patent Extension Application from Sterne Kessler Godlstein & Fox PLLC (on behalf of…
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858. FDA-2016-V-2448-0002Acknowledgement Letter from FDA DDM to Crux Events
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863. FDA-2010-N-0001-0069See Docket FDA-2010-D-0249
864. FDA-2004-N-0308-0004Supporting Statement for OMB Review - Infant Feeding Practices Study II
865. FDA-2020-S-0024-01072020-414 Nartex Labs USA - MULTIPLE CLAIMS (9)
866. FDA-2023-H-1964-0001Complaint
867. FDA-2023-H-5325-0001Complaint
868. FDA-2015-P-4529-0010Exhibit K Investor Statement on Board Oversight of BIosimilar Issues re: Citizen Petition…
869. FDA-2012-S-1144-0349NBTY, Inc. - Glucosamine Hyaluronic Acid Chondroitin MSM - Promotes Healthy Joints
870. FDA-2016-P-3696-0002Acknowledgment Letter from FDA DDM to ANDA Consultants
871. FDA-2007-D-0369-1517PSG_021676 - Draft Guidance on Drospirenone; Ethinyl Estradiol
872. FDA-1990-F-0342-0004Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
873. FDA-2013-N-1043-0023Reference 12-FDA Recalls, Market Withdrawals, & Safety Alerts _ Primal Pet Foods…
874. FDA-1993-G-0218-0230Section 2/Subsection F of Reference 51 - Snowite® Oat Fiber Nutritional Information (two)…
875. FDA-2019-H-5375-0001Complaint
876. FDA-1975-N-0007-0183Chapter IV -Biochemical, Ten-State Nutrition Survey, 1968-1970, U.S. Department of Health…
877. FDA-2016-H-2155-0001Complaint
878. FDA-2022-E-2263-0005Letter from FDA CDER to U.S. Patent and Trademark Office
879. FDA-2014-N-0053-1311Reference 27 - FDA Draft Guidance for Industry-Classification of Activities as Harvesting…
880. FDA-1992-N-0026-0004Proposed Implementation of International Conference on Harmonisation Consensus Regarding…
881. FDA-2020-D-1530-0031Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities…
882. FDA-2025-H-1888-0001Complaint
883. FDA-2018-H-1585-0001Complaint
884. FDA-2019-H-4137-0001Complaint
885. FDA-2021-N-1349-0367PRIA Reference 58 Pletcher Menthol Cigarettes Smoking Cessation Atherosclerosis and…
886. FDA-2021-V-1002-0002Acknowledgement Letter from FDA DMS to Cuttlefish Inc
887. FDA-2013-N-1524-1886Nomination Letter Aluminum Hydroxide Gel Dried re: Comment from Fagron
888. FDA-1990-G-0246-0116Annex 1 - Calculation of Residues
889. FDA-2010-P-0628-0001Heyltex Corporation, Heyl Chemisch-Pharmazeutische Fabrik GnbH & Co. KG - Citizen Petition
890. FDA-2014-N-0189-4893Request for Extension from Anonymous
891. FDA-2011-N-0921-19145List of references re Standards for the Growing, Harvesting, Packing, and Holding of…
892. FDA-2015-H-4940-0001CTP CMP Case re LM Super Discount Inc. d/b/a LM Super Discount
893. FDA-2025-H-3567-0001Complaint
894. FDA-2025-S-0024-08452025-000385 - Nuchido - Nuchido Time - Boost NAD+ & Support Cellular Health
895. FDA-2012-N-0378-0042Regenesis Biomedical Inc - Change in Classification Petition
896. FDA-2024-S-0024-07322024-001569 - New Generation Wellness Inc. - specifically formulated to help babies reach…
897. FDA-2009-S-0607-0248Perrigo - Good Neighbor Pharmacy - One Daily - Promotes Bone Strength
898. FDA-2003-D-0089-0075Background Material
899. FDA-1993-N-0297-0024Tab E Draft Letter from FDA CBER to Central Georgia Plasma Lab, Inc. (August 21, 1996) re…
900. FDA-2017-H-1866-0001CMP Complaint Issued to Holiday Trails Resorts (U.S.), Inc. d/b/a The Cedars R.V. Resort
901. FDA-2014-V-0562-0001Variance Application from DJBABYPAISA
902. FDA-1999-N-0134-0033Risk Assessment
903. FDA-2017-P-4334-0012Tab 29 Highlights of Prescribing Information re Citizen Petition from Sidley Austin LLP…
904. FDA-2019-H-0307-0001Complaint
905. FDA-2019-Q-0806-0093Hollenberg - Flavanols, the Kuna
906. FDA-2016-P-3418-0071Attachment 68 Guidance for Industry, Bioavailablity and Bioequivalence Studies for Orally…
907. FDA-2018-S-0023-0037NDI 1064- Creatine Acesulfame - Original Notification
908. FDA-2007-D-0369-1214PSG_018200 - Draft Guidance on Amiloride Hydrochloride
909. FDA-2001-P-0123-0044Acknowledgement Letter to the Center for Reproductive Law & Policy (Simon Heller)
910. FDA-2018-H-2184-0001Complaint
911. FDA-1993-G-0218-0012Letter from FDA/CFSAN to Canadian Harvest, U. S. A., L. P.
912. FDA-2022-S-0024-03092022-000290 - Madison One Acme Inc. - Lian Qiao Pai Du Qing Wen Capsule Herbal Supplement…
913. FDA-1991-N-0304-0033Supplement from National Association of Chewing Gum Manufacturers
914. FDA-2017-P-4575-0188Reference 178 - Table 3 Fatty acids profile of two test diets in Experiment II
915. FDA-2022-P-1060-0006Tab 4 re Suitability Petition from The Wood Burditt Group LLC
916. FDA-2019-H-2724-0001Complaint
917. FDA-2014-N-1051-0577576 7694105 RDC CRF Subject R5015_Redacted
918. FDA-2015-V-0604-0001Variance Application from IMAGOS Entertainment LLC
919. FDA-1997-S-0006-0198FDA/CFSAN to Immunotec Research Inc
920. FDA-2023-E-2391-0002Patent Extension Application from Axar Pharmaceuticals, Inc. (on behalf of Tap…
921. FDA-2015-N-0101-0185Reference 7-176 - FDA-1975-N-0012-0081 -- C12 Ref - 174_Selwyn_Ellis 1972 re Safety and…
922. FDA-2024-S-0024-10692024-001948 - Clean 24 Hour - Clean24Hour - Help digestion and improve bowel movement
923. FDA-2012-F-0138-0009Reference 1 - Committee to Review Dietary Reference Intakes for Vitamin D and Calcium…
924. FDA-2010-D-0094-1075The PEW Charitable Trusts to the Food and Drug Administration (FDA), July 12, 2012 - (re…
925. FDA-1976-N-0031-0243Petition for Stay of Action from Dow Chemical U. S. A.
926. FDA-2023-N-2177-0034PRIA Reference 51 - I. Eastern Research Group - Economic Analysis of CDRH Submission…
927. FDA-2018-D-1638-0011Pediatric HIV Infection Drug Product Development for Treatment
928. FDA-2020-E-1896-0006Letter from U.S. Patent and Trademark Office to FDA CDER
929. FDA-2013-N-0579-0005Agency Information Collection Activities; Submission for Office of Management and Budget…
930. FDA-2008-N-0038-0074Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice…
931. FDA-2007-N-0437-0001Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug…
932. FDA-2010-N-0001-0163Meetings: Pulmonary-Allergy Drugs Advisory Committee
933. FDA-1997-S-0039-1311Perrigo Company of South Carolina - Vitasmart - Calcium Citrate+, Member's Mark Calcium…
934. FDA-2025-H-3037-0001Complaint
935. FDA-1981-F-0048-0001Abbott Laboratories; Withdrawal of Food Additive Petition
936. FDA-1975-N-0012-0648Memorandum of Meeting Minutes Between FDA CDER and Lonza America, Inc
937. FDA-2015-H-4234-0001CTP CMP Case re Laith and R Mini Mart, Inc. d/b/a Valero
938. FDA-2011-M-0865-0002Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval…
939. FDA-2024-S-0024-08452024-001717 - Sovereign Nature LLC - Sovereign Nature, HuVic Gold - May Help Maintain a…
940. FDA-1998-D-0025-0017Meeting Between the Institute for Clinical PET and FDA Staff On Approval Procedures for…
941. FDA-2024-H-4571-0001Complaint
942. FDA-2005-N-0402-0001Agency Information Collection Activities; Proposed Collection; Comment Request; Financial…
943. FDA-2023-N-1052-0002Request for Extension from Pharmaceutical Research and Manufacturers of America (PhRMA)
944. FDA-2018-H-2799-0001Complaint
945. FDA-2003-E-0264-0001U S Patent and Trademark Office
946. FDA-2025-H-4420-0001Complaint
947. FDA-2014-N-0189-42643Request for Extension from Mathew Chaney
948. FDA-1994-P-0041-0154BACKGROUND
949. FDA-2015-P-4959-0001Citizen Petition from Cardinal Health Regulatory Sciences
950. FDA-2016-V-3702-0002Acknowledgement Letter from FDA DDM to JAMMIN’ DJs - Colorado
951. FDA-1999-D-0081-0052Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent…
952. FDA-2017-H-0620-0001CMP Complaint from FDA CTP to JJJ Auto Retailers, Inc. d/b/a High Street Express
953. FDA-2019-M-2408-0001Premarket Approval Response from FDA CDRH to Stryker Neurovascular
954. FDA-2012-E-0851-0004Letter to U. S. Patent and Trademark Office
955. FDA-2012-P-0299-0003Range Equine Rescue and the Humane Society of the U.S. (Schiff Hardin LLP) - Citizen…
956. FDA-2016-H-2926-0001Complaint
957. FDA-2016-M-1125-0001Premarket Approval Response from FDA CDRH to Medtronic, Inc. Micra Transcatheter Pacing…
958. FDA-2015-H-3792-0001CTP CMP Case re Low Cost Supermarket, Inc.
959. FDA-1978-N-1446-0039Reference E Product Information on Emetrol re: Supplement from William H. Rorer, Inc.
960. FDA-2015-N-0101-1233Econ Reference 31 - Bureau of Labor Statistics re Safety and Effectiveness of Health Care…
961. FDA-2020-N-0002-0007FOI Summary oA 200-586, approved March 23, 2020 re New Animal Drugs; Approval of New…
962. FDA-2019-N-3065-0008Reference 6 - Vital Signs_Tobacco Product Use Among Middle and High School…
963. FDA-2007-D-0369-0751Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Reopening of…
964. FDA-2015-N-1355-0019Attachment 4 Redacted List of Cetylite's communications with DAAAP re: Comment from Keller…
965. FDA-2024-H-1480-0001Complaint
966. FDA-1991-N-0365-0336Answer from FDA DDM to Honorable Gaylord Nelson Re: Comment from John G. Strange
967. FDA-2020-S-0024-03422020-000451 NOW Foods- Spring Valley, Detox & Cleanse Support- support the body’s…
968. FDA-2024-N-5471-0003Reference 1 - HHS The health consequences of smoking 2014
969. FDA-1991-N-0042-0038References for NPR1 published 11/27/1991
970. FDA-2011-F-0172-0574A Labeling Guide for Restaurants and Retail Establishments Selling Away- From-Home…
971. FDA-2023-H-4152-0001Complaint
972. FDA-2022-S-0024-07512022-000809 - Market America - Daily Greens - Aids in supplementing the body with enzymes…
973. FDA-2019-H-4936-0001Complaint
974. FDA-2015-D-1211-0098Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission…
975. FDA-2015-S-0024-1723America's Finest, Inc. - Super Curcumin C3 Complex® w/BioPerine - BioPerine improves the…
976. FDA-1977-N-0014-1428Answer from FDA to Comment from the Honorable Senator Bob Packwood
977. FDA-2011-S-0932-2378FoodScience Corporation - Ubiquinol 100 mg - A Dietary Supplement
978. FDA-2018-S-0024-0652Weleda- Amara Drops- Supports normal digestion
979. FDA-2024-P-1715-0004Interim Response Letter from FDA CDER to AbbVie Inc.
980. FDA-2018-H-2925-0001Complaint
981. FDA-2024-H-1439-0001Complaint
982. FDA-2025-P-5430-0005Attachment 3 - Orange Book Edition 43 Annual INAPSINE Listed as RLD and RS - Therapeutic…
983. FDA-1987-N-0010-0266Background Material
984. FDA-2024-H-2468-0001Complaint
985. FDA-2021-V-0657-0001Variance Application from Open Systems Integrators Inc
986. FDA-2014-S-0024-0644Perrigo Company (H E B - Senior Complete) - Letter
987. FDA-1997-S-0039-1799Perrigo Company of South Carolina - Today's Health - Multi Vitamins - Nutrients Your Child…
988. FDA-2022-H-1453-0001Complaint
989. FDA-1977-N-0002-1587Answer Letter from FDA to Comment from the Honorable Senator Edward Zorinsky
990. FDA-2009-S-0608-0058Background Material re NDI 304 - Extract of Garcinia Cambogia (Cool Water Trim)
991. FDA-1995-V-0060-0009Acknowledgement Letter to Production Design IntNatl Inc.
992. FDA-2022-P-1982-0004Response Letter from FDA CDER to Nines Consult Pharma, LLC
993. FDA-2023-P-4325-0005Attachment 3 Highlights of Prescribing Information re Suitability Petition from Hyman…
994. FDA-2015-S-0024-0076NBTY Inc - Prenatal supplements under the Walgreens label - Pregnancy health
995. FDA-2023-V-2344-0001Variance Application from Richard Nicol
996. FDA-2017-H-5068-0001Complaint
997. FDA-1999-N-0113-0032Background Information
998. FDA-2015-N-0101-0943Reference 39-77 - FDA-1975-N-0012-0285 --- C81 Steris 8-26-2003 re Safety and…
999. FDA-2022-V-2779-0002Acknowledgment Letter from FDA DMS to Nathan Woodruff
1000. FDA-2022-S-0024-10502022-001092 - NOW Foods - NOW Foods, Vitamin D-3 2000 IU - Supports bone and immune…