Orca1

Data catalog

FDA guidance documents

About 7,072 records

All records

Every FDA guidance record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

  1. 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day
  2. 180-Day Generic Drug Exclusivity Under the Hatch-Waxman Amendments to the Federal Food…
  3. 1993 Draft Redbook II
  4. 1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry…
  5. 行业指南草案：关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答 (第2版) (Chinese Translation of Draft Guidance for…
  6. 行业指南草案：关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答 (第2版) (Chinese Translation of Guidance for…
  7. 行业指南：关于美国食品药品管理局2007年修正法案规定的应通报食品注册的问答 (Chinese Translation of the Guidance for Industry…
  8. 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry…
  9. 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian…
  10. 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical…
  11. 510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants
  12. 510(k) Submissions for Coagulation Instruments
  13. 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA)…
  14. 510(k) Third Party Review Program: Guidance for Industry, Food and Drug Administration…
  15. 590.600 WigsCompliance Policy Guide 7128.05
  16. ABACAVIR and LAMIVUDINE, ABACAVIR SULFATE - LAMIVUDINE (TABLET - ORAL), [MYLAN…
  17. Abacavir Sulfate; Dolutegravir Sodium; Lamivudine (Tablet, For Suspension - Oral)
  18. Abacavir Sulfate; Dolutegravir Sodium; Lamivudine (Tablet - Oral)
  19. Abacavir Sulfate; Lamivudine (Tablet - Oral)
  20. Abacavir Sulfate; Lamivudine (Tablet - Oral)
  21. Abacavir Sulfate; Lamivudine; Zidovudine (Tablet - Oral)
  22. Abacavir Sulfate; Lamivudine; Zidovudine (Tablet - Oral)
  23. Abacavir Sulfate (Tablet - Oral)
  24. Abacavir Sulfate (Tablet - Oral)
  25. Abametapir (Lotion - Topical)
  26. Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators
  27. Abemaciclib (Tablet - Oral)
  28. Abemaciclib (Tablet - Oral)
  29. ABILIFY, ARIPIPRAZOLE (INJECTABLE - INTRAMUSCULAR), [OTSUKA]
  30. ABILIFY, ARIPIPRAZOLE (SOLUTION - ORAL), [OTSUKA]
  31. ABILIFY, ARIPIPRAZOLE (TABLET, ORALLY DISINTEGRATING - ORAL), [OTSUKA]
  32. ABILIFY, ARIPIPRAZOLE (TABLET - ORAL), [OTSUKA]
  33. ABILIFY ASIMTUFII, ARIPIPRAZOLE MONOHYDRATE (EXTENDED-RELEASE, INJECTABLE SUSPENSION…
  34. ABILIFY MAINTENA KIT, ARIPIPRAZOLE (FOR SUSPENSION, EXTENDED RELEASE - INTRAMUSCULAR)…
  35. ABILIFY MYCITE KIT, ARIPIPRAZOLE (TABLET - ORAL), [OTSUKA]
  36. Abiraterone Acetate (Tablet - Oral)
  37. Abiraterone Acetate (Tablet - Oral)
  38. ABRILADA, ADALIMUMAB-AFZB (INJECTABLE - INJECTION), [PFIZER INC]
  39. Abrocitinib (Tablet - Oral)
  40. ABSORICA, ISOTRETINOIN (CAPSULE - ORAL), [SUN PHARM INDS INC]
  41. ABSTRAL, FENTANYL CITRATE (TABLET - SUBLINGUAL), [SENTYNL THERAPS INC]
  42. Abuse-Deterrent Opioids-Evaluation and Labeling
  43. Acalabrutinib (Capsule - Oral)
  44. Acalabrutinib (Capsule - Oral)
  45. Acalabrutinib Maleate (Tablet - Oral)
  46. Acamprosate Calcium (Tablet, Delayed Release - Oral)
  47. Acarbose (Tablet - Oral)
  48. Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is…
  49. Accelerated Approval – Expedited Program for Serious Conditions
  50. Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval…
  51. Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff
  52. Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for…
  53. Acceptance of Clinical Data to Support Medical Device Applications and Submissions…
  54. Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and…
  55. Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for…
  56. ACCUTANE, ISOTRETINOIN (CAPSULE - ORAL), [HOFFMANN LA ROCHE]
  57. Acetaminophen; Aspirin; Caffeine (Tablet - Oral)
  58. Acetaminophen; Aspirin; Caffeine (Tablet - Oral)
  59. Acetaminophen; Benzhydrocodone Hydrochloride (Tablet - Oral)
  60. Acetaminophen; Butalbital; Caffeine (Capsule - Oral)
  61. Acetaminophen; Butalbital; Caffeine; Codeine Phosphate (Capsule - Oral)
  62. Acetaminophen; Butalbital; Caffeine; Codeine Phosphate (Capsule - Oral)
  63. Acetaminophen; Butalbital; Caffeine (Tablet - Oral)
  64. Acetaminophen; Butalbital (Capsule - Oral)
  65. Acetaminophen; Butalbital (Tablet - Oral)
  66. Acetaminophen; Caffeine; Dihydrocodeine Bitartrate (Capsule - Oral)
  67. Acetaminophen; Caffeine; Dihydrocodeine Bitartrate (Tablet - Oral)
  68. Acetaminophen; Codeine Phosphate (Tablet - Oral)
  69. Acetaminophen; Hydrocodone Bitartrate (Tablet - Oral)
  70. Acetaminophen; Ibuprofen (Tablet - Oral)
  71. Acetaminophen; Oxycodone Hydrochloride (Tablet, Extended Release - Oral)
  72. Acetaminophen; Oxycodone Hydrochloride (Tablet - Oral)
  73. Acetaminophen; Propoxyphene Napsylate (Tablet - Oral)
  74. Acetaminophen; Propoxyphene Napsylate (Tablet - Oral)
  75. Acetaminophen (Suppository - Rectal)
  76. Acetaminophen (Tablet, Extended Release - Oral)
  77. Acetaminophen; Tramadol Hydrochloride (Tablet - Oral)
  78. Acetaminophen; Tramadol Hydrochloride (Tablet - Oral)
  79. Acetazolamide (Capsule, Extended Release - Oral)
  80. Acetazolamide (Tablet - Oral)
  81. Acetazolamide (Tablet - Oral)
  82. Acetylcysteine (Tablet, Effervescent - Oral)
  83. Acetylcysteine (Tablet, Effervescent - Oral)
  84. ACIPHEX, RABEPRAZOLE SODIUM (TABLET, DELAYED RELEASE - ORAL), [WOODWARD]
  85. ACIPHEX SPRINKLE, RABEPRAZOLE SODIUM (CAPSULE, DELAYED RELEASE - ORAL), [AYTU]
  86. Acitretin (Capsule - Oral)
  87. Aclidinium Bromide; Formoterol Fumarate (Powder, Metered - Inhalation)
  88. Aclidinium Bromide (Powder, Metered - Inhalation)
  89. Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment
  90. Acrivastine; Pseudoephedrine Hydrochloride (Capsule - Oral)
  91. Acrivastine; Pseudoephedrine Hydrochloride (Capsule - Oral)
  92. Acromegaly: Developing Drugs for Treatment
  93. ACTEMRA, TOCILIZUMAB (INJECTABLE - INJECTION), [GENENTECH]
  94. ACTEMRA, TOCILIZUMAB (INJECTABLE - INTRAVENOUS, SUBCUTANEOUS), [GENENTECH]
  95. ACTHAR GEL, CORTICOTROPIN (INJECTABLE - INJECTION), [MALLINCKRODT ARD]
  96. Action Level for Inorganic Arsenic in Apple Juice
  97. ACTIQ, FENTANYL CITRATE (TROCHE/LOZENGE - TRANSMUCOSAL), [CEPHALON]
  98. ACTONEL, RISEDRONATE SODIUM (TABLET - ORAL), [APIL]
  99. ACTONEL WITH CALCIUM (COPACKAGED), CALCIUM CARBONATE - RISEDRONATE SODIUM (TABLET - ORAL)…
  100. ACTOPLUS MET, METFORMIN HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE (TABLET - ORAL)…
  101. ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE - PIOGLITAZONE HYDROCHLORIDE (TABLET, EXTENDED…
  102. ACTOS, PIOGLITAZONE HYDROCHLORIDE (TABLET - ORAL), [TAKEDA PHARMS USA]
  103. Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive…
  104. Acute Bacterial Exacerbations of Chronic Bronchitis in Patients with Chronic Obstructive…
  105. Acute Bacterial Sinusitis — Developing Antimicrobial Drugs for Treatment
  106. Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment
  107. Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Draft…
  108. Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Guidance…
  109. Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment
  110. Acyclovir (Capsule - Oral)
  111. Acyclovir (Capsule - Oral)
  112. Acyclovir (Cream - Topical)
  113. Acyclovir; Hydrocortisone (Cream - Topical)
  114. Acyclovir (Ointment - Ophthalmic)
  115. Acyclovir (Ointment - Topical)
  116. Acyclovir (Suspension - Oral)
  117. Acyclovir (Tablet - Buccal)
  118. Acyclovir (Tablet - Oral)
  119. Acyclovir (Tablet - Oral)
  120. Adagrasib (Tablet - Oral)
  121. Adapalene; Benzoyl Peroxide; Clindamycin Phosphate (Gel - Topical)
  122. Adapalene; Benzoyl Peroxide (Gel - Topical)
  123. Adapalene (Cream - Topical)
  124. Adapalene (Gel - Topical)
  125. Adapalene (Lotion - Topical)
  126. Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry
  127. Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and…
  128. ADASUVE, LOXAPINE (POWDER - INHALATION), [ALEXZA PHARMS]
  129. Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers…
  130. ADDERALL 10, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  131. ADDERALL 12.5, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  132. ADDERALL 15, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  133. ADDERALL 20, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  134. ADDERALL 30, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  135. ADDERALL 5, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  136. ADDERALL 7.5, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  137. ADDERALL XR 10, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  138. ADDERALL XR 15, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  139. ADDERALL XR 20, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  140. ADDERALL XR 25, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  141. ADDERALL XR 30, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  142. ADDERALL XR 5, AMPHETAMINE ASPARTATE - AMPHETAMINE SULFATE - DEXTROAMPHETAMINE SACCHARATE…
  143. Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen…
  144. Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and…
  145. Addition of URLs to Electronic Product Labeling: Guidance for Industry and FDA Staff
  146. Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and…
  147. ADDYI, FLIBANSERIN (TABLET - ORAL), [SPROUT PHARMS]
  148. Adefovir Dipivoxil (Tablet - Oral)
  149. Adefovir Dipivoxil (Tablet - Oral)
  150. ADEMPAS, RIOCIGUAT (TABLET - ORAL), [BAYER HLTHCARE]
  151. Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface…
  152. ADHANSIA XR, METHYLPHENIDATE HYDROCHLORIDE (CAPSULE, EXTENDED RELEASE - ORAL), [PURDUE…
  153. Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
  154. ADLYXIN, LIXISENATIDE (SOLUTION - SUBCUTANEOUS), [SANOFI-AVENTIS US]
  155. Administrative Procedures for CLIA Categorization: Guidance for Industry and Food and Drug…
  156. ADUHELM, ADUCANUMAB-AVWA (INJECTABLE - INJECTION), [BIOGEN INC]
  157. Advanced Manufacturing Technologies Designation Program
  158. Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for…
  159. Advancement of Emerging Technology Applications for Pharmaceutical Innovation and…
  160. Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food…
  161. Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for…
  162. Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products…
  163. ADZENYS ER, AMPHETAMINE (SUSPENSION, EXTENDED RELEASE - ORAL), [NEOS THERAPS INC]
  164. ADZENYS XR-ODT, AMPHETAMINE (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE - ORAL)…
  165. Afamelanotide (Implant - Subcutaneous)
  166. Afatinib Dimaleate (Tablet - Oral)
  167. AFREZZA, INSULIN RECOMBINANT HUMAN (POWDER - INHALATION), [MANNKIND]
  168. A Guide for the Submission of An Abbreviated Radiation Safety Reports on Cephalometric…
  169. A Guide For The Submission of an Abbreviated Report on X-ray Tables, Cradles, Film…
  170. A Guide to Informed Consent: Guidance for Institutional Review Boards and Clinical…
  171. Air Polymer-Type A (Foam - Intrauterine)
  172. Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and…
  173. Albendazole (Tablet, Chewable - Oral)
  174. Albendazole (Tablet - Oral)
  175. Albuterol Sulfate (Aerosol, Metered - Inhalation)
  176. Albuterol Sulfate; Ipratropium Bromide (Spray, Metered - Inhalation)
  177. Albuterol Sulfate (Powder, Metered - Inhalation)
  178. Albuterol Sulfate (Tablet, Extended Release - Oral)
  179. Albuterol Sulfate (Tablet - Oral)
  180. Albuterol Sulfate (Tablet - Oral)
  181. Alcaftadine (Solution/Drops - Ophthalmic)
  182. Alcoholism: Developing Drugs for Treatment
  183. Alectinib Hydrochloride (Capsule - Oral)
  184. Alendronate Sodium; Cholecalciferol (Tablet - Oral)
  185. Alendronate Sodium (Tablet, Effervescent - Oral)
  186. Alendronate Sodium (Tablet - Oral)
  187. Alfuzosin Hydrochloride (Tablet, Extended Release - Oral)
  188. Aliskiren Hemifumarate; Amlodipine Besylate (Tablet - Oral)
  189. Aliskiren Hemifumarate; Hydrochlorothiazide (Tablet - Oral)
  190. Aliskiren Hemifumarate (Tablet - Oral)
  191. Aliskiren Hemifumarate; Valsartan (Tablet - Oral)
  192. ALKINDI SPRINKLE, Hydrocortisone (GRANULE - ORAL), [ETON]
  193. Allergic Rhinitis: Developing Drug Products for Treatment Guidance for Industry
  194. All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46)…
  195. Allopurinol; Lesinurad (Tablet - Oral)
  196. Allopurinol; Lesinurad (Tablet - Oral)
  197. Allopurinol (Suspension - Oral)
  198. Allopurinol (Tablet - Oral)
  199. Allopurinol (Tablet - Oral)
  200. Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological…
  201. All U.S. Condom Manufacturers, Importers and Repackagers
  202. Almotriptan Malate (Tablet - Oral)
  203. Almotriptan Malate (Tablet - Oral)
  204. Alogliptin Benzoate; Metformin Hydrochloride (Tablet - Oral)
  205. Alogliptin Benzoate; Metformin Hydrochloride (Tablet - Oral)
  206. Alogliptin Benzoate; Pioglitazone Hydrochloride (Tablet - Oral)
  207. Alogliptin Benzoate; Pioglitazone Hydrochloride (Tablet - Oral)
  208. Alogliptin Benzoate (Tablet - Oral)
  209. Alogliptin Benzoate (Tablet - Oral)
  210. Alosetron Hydrochloride (Tablet - Oral)
  211. Alosetron Hydrochloride (Tablet - Oral)
  212. Alpelisib (Tablet - Oral)
  213. Alprazolam (Tablet, Extended Release - Oral)
  214. Alprazolam (Tablet - Oral)
  215. Alprazolam (Tablet - Oral)
  216. Alprazolam (Tablet, Orally Disintegrating - Oral)
  217. Alprostadil (Suppository - Urethral)
  218. Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs: Guidance for…
  219. Alternate Wording For Caution Statement (Laser Notice 30)
  220. Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health…
  221. Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the…
  222. Alternative to Certain Prescription Device Labeling Requirements - Guidance for Industry
  223. Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending…
  224. Altretamine (Capsule - Oral)
  225. ALVAIZ, ELTROMBOPAG CHOLINE (TABLET - ORAL), [TEVA PHARMACEUTICALS]
  226. Alvimopan (Capsule - Oral)
  227. Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industy
  228. Amantadine Hydrochloride (Capsule, Extended Release - Oral)
  229. Amantadine Hydrochloride (Capsule - Oral)
  230. Amantadine Hydrochloride (Capsule - Oral)
  231. Amantadine Hydrochloride (Tablet, Extended Release - Oral)
  232. Amantadine Hydrochloride (Tablet - Oral)
  233. Amantadine Hydrochloride (Tablet - Oral)
  234. AMBIEN CR, ZOLPIDEM TARTRATE (TABLET, EXTENDED RELEASE - ORAL), [SANOFI AVENTIS US]
  235. AMBIEN, ZOLPIDEM TARTRATE (TABLET - ORAL), [SANOFI AVENTIS US]
  236. Ambrisentan (Tablet - Oral)
  237. Ambrisentan (Tablet - Oral)
  238. Amcinonide (Lotion - Topical)
  239. Amifampridine Phosphate (Tablet - Oral)
  240. Amiloride Hydrochloride (Tablet - Oral)
  241. Amiloride Hydrochloride (Tablet - Oral)
  242. Amino Acids;Calcium Chloride;Dextrose;Magnesium Sulfate;Potassium Chloride;Sodium…
  243. Aminocaproic Acid (Tablet - Oral)
  244. Aminocaproic Acid (Tablet - Oral)
  245. Aminosalicylic Acid (Granule, Delayed Release - Oral)
  246. Amiodarone Hydrochloride (Tablet - Oral)
  247. Amiodarone Hydrochloride (Tablet - Oral)
  248. Amisulpride (Solution - Intravenous)
  249. Amitriptyline Hydrochloride; Chlordiazepoxide (Tablet - Oral)
  250. Amitriptyline Hydrochloride; Chlordiazepoxide (Tablet - Oral)
  251. Amitriptyline Hydrochloride (Tablet - Oral)
  252. Amitriptyline Hydrochloride (Tablet - Oral)
  253. AMJEVITA, ADALIMUMAB-ATTO (INJECTABLE - INJECTION), [AMGEN INC]
  254. Amlodipine Benzoate (Suspension - Oral)
  255. Amlodipine Besylate; Atorvastatin Calcium (Tablet - Oral)
  256. Amlodipine Besylate; Atorvastatin Calcium (Tablet - Oral)
  257. Amlodipine Besylate; Benazepril Hydrochloride (Capsule - Oral)
  258. Amlodipine Besylate; Benazepril Hydrochloride (Capsule - Oral)
  259. Amlodipine Besylate; Celecoxib (Tablet - Oral)
  260. Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil (Tablet - Oral)
  261. Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil (Tablet - Oral)
  262. Amlodipine Besylate;Hydrochlorothiazide;Valsartan (Tablet - Oral)
  263. Amlodipine Besylate; Hydrochlorothiazide; Valsartan (Tablet - Oral)
  264. Amlodipine Besylate; Olmesartan Medoxomil (Tablet - Oral)
  265. Amlodipine Besylate; Olmesartan Medoxomil (Tablet - Oral)
  266. Amlodipine Besylate; Perindopril Arginine (Tablet - Oral)
  267. Amlodipine Besylate; Perindopril Arginine (Tablet - Oral)
  268. Amlodipine Besylate (Tablet - Oral)
  269. Amlodipine Besylate (Tablet - Oral)
  270. Amlodipine Besylate; Telmisartan (Tablet - Oral)
  271. Amlodipine Besylate; Valsartan (Tablet - Oral)
  272. Amlodipine Besylate; Valsartan (Tablet - Oral)
  273. Ammonium Lactate (Cream - Topical)
  274. Ammonium Lactate (Lotion - Topical)
  275. Amoxicillin (Capsule - Oral)
  276. Amoxicillin (Capsule - Oral)
  277. Amoxicillin; Clarithromycin; Omeprazole (Capsule, Tablet, Capsule, Delayed Release - Oral)
  278. Amoxicillin; Clarithromycin; Vonoprazan Fumarate (Capsule; Tablet; Tablet - Oral)
  279. Amoxicillin; Clavulanate Potassium (For Suspension - Oral)
  280. Amoxicillin; Clavulanate Potassium (Suspension - Oral)
  281. Amoxicillin; Clavulanate Potassium (Suspension - Oral)
  282. Amoxicillin; Clavulanate Potassium (Tablet, Chewable - Oral)
  283. Amoxicillin; Clavulanate Potassium (Tablet, Chewable - Oral)
  284. Amoxicillin; Clavulanate Potassium (Tablet, Extended Release - Oral)
  285. Amoxicillin; Clavulanate Potassium (Tablet - Oral)
  286. Amoxicillin; Clavulanate Potassium (Tablet - Oral)
  287. Amoxicillin (For Suspension - Oral)
  288. Amoxicillin; Omeprazole Magnesium; Rifabutin (Capsule, Delayed Release - Oral)
  289. Amoxicillin (Suspension - Oral)
  290. Amoxicillin (Tablet, Chewable - Oral)
  291. Amoxicillin (Tablet, Extended Release - Oral)
  292. Amoxicillin; Vonoprazan Fumarate (Capsule; Tablet - Oral)
  293. Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate (Tablet, Extended Release…
  294. Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate…
  295. Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate…
  296. Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate…
  297. Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate…
  298. Amphetamine Sulfate (Tablet - Oral)
  299. Amphetamine (Suspension, Extended Release - Oral)
  300. Amphetamine (Suspension, Extended Release - Oral)
  301. Amphetamine (Tablet, Orally Disintegrating, Extended Release - Oral)
  302. Amphotericin B (Injectable, Liposomal - Injection)
  303. Ampicillin/Ampicillin Trihydrate (Capsule - Oral)
  304. Amprenavir (Capsule - Oral)
  305. AMPYRA, DALFAMPRIDINE (TABLET, EXTENDED RELEASE - ORAL), [ACORDA]
  306. Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry…
  307. An Acceptable Circular of Information for the Use of Human Blood and Blood Components…
  308. ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE (CAPSULE - ORAL), [SPECGX LLC]
  309. Anagrelide Hydrochloride (Capsule - Oral)
  310. Anagrelide Hydrochloride (Capsule - Oral)
  311. Analytical Procedures and Methods Validation for Drugs and Biologics
  312. ANAPROX DS, NAPROXEN SODIUM (TABLET - ORAL), [ATNAHS PHARMA US]
  313. ANAPROX, NAPROXEN SODIUM (TABLET - ORAL), [ATNAHS PHARMA US]
  314. Anastrozole (Tablet - Oral)
  315. Anastrozole (Tablet - Oral)
  316. ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed…
  317. ANDAs: Impurities in Drug Products: Guidance for Industry
  318. ANDAs: Impurities in Drug Substances: Guidance for Industry
  319. ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls…
  320. ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug…
  321. ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug…
  322. ANDAs: Stability Testing of Drug Substances and Products
  323. ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
  324. ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved…
  325. ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA: Guidance…
  326. ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for…
  327. ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry
  328. ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits…
  329. ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for…
  330. ANDA Submissions -- Refuse-to-Receive Standards Rev.2
  331. ANDROGEL, TESTOSTERONE (GEL, METERED - TRANSDERMAL), [ABBVIE]
  332. ANDROGEL, TESTOSTERONE (GEL - TRANSDERMAL), [ABBVIE]
  333. Angiotensin II Acetate (Solution - Intravenous)
  334. Animal Models — Essential Elements to Address Efficacy Under the Animal Rule_09
  335. Animal Models — Essential Elements to Address Efficacy Under the Animal Rule - Concept…
  336. Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k))…
  337. Annex 13 Bulk Density and Tapped Density of Powders General Chapter
  338. Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug…
  339. Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics…
  340. Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry…
  341. Annual Status Report Information and Other Submissions for Postmarketing Requirements and…
  342. ANSAID, FLURBIPROFEN (TABLET - ORAL), [PHARMACIA AND UPJOHN]
  343. Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industry
  344. Antibacterial Drug Products: Use of Noninferiority Studies to Support Approval
  345. Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of…
  346. Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of…
  347. Antidepressant Drugs--Clinical Evaluation
  348. Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device…
  349. Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency…
  350. Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency
  351. Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency…
  352. Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency…
  353. Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency…
  354. APADAZ, ACETAMINOPHEN - BENZHYDROCODONE HYDROCHLORIDE (TABLET - ORAL), [KVK TECH INC]
  355. Apalutamide (Tablet - Oral)
  356. Apalutamide (Tablet - Oral)
  357. Apixaban (Tablet - Oral)
  358. APLENZIN, BUPROPION HYDROBROMIDE (TABLET, EXTENDED RELEASE - ORAL), [BAUSCH]
  359. Apomorphine Hydrochloride (Film - Sublingual)
  360. Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation…
  361. Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps…
  362. Application of Human Factors Engineering Principles for Combination Products: Questions…
  363. Application of the Device Good Manufacturing Practice (GMP) Regulation to the Manufacture…
  364. Applications Covered by Section 505(b)(2)
  365. Applications for Premarket Review of New Tobacco Products: Draft Guidance for Industry
  366. Application User Fees for Combination Products: Guidance for Industry and FDA Staff
  367. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry…
  368. Approaches to Assessment of Overall Survival in Oncology Clinical Trials: Draft Guidance…
  369. Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical…
  370. Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53)
  371. Apremilast (Tablet - Oral)
  372. Apremilast (Tablet - Oral)
  373. Aprepitant (Capsule - Oral)
  374. Aprepitant (Emulsion - Intravenous)
  375. Aprepitant (Suspension - Oral)
  376. APTENSIO XR, METHYLPHENIDATE HYDROCHLORIDE (CAPSULE, EXTENDED RELEASE - ORAL), [RHODES…
  377. APTIOM, ESLICARBAZEPINE ACETATE (TABLET - ORAL), [SUNOVION PHARMS INC]
  378. APTRYXOL, DESVENLAFAXINE (TABLET,EXTENDED RELEASE - ORAL), [SUN PHARMACEUTICAL]
  379. Aqueous Shunts - 510(k) Submissions - Guidance for Industry and for FDA Reviewers/Staff
  380. ARANESP, DARBEPOETIN ALFA (VIAL - INTRAVENOUS), [AMGEN]
  381. ARANESP, DARBEPOETIN ALFA (VIAL - SUBCUTANEOUS), [AMGEN]
  382. ARCAPTA NEOHALER, INDACATEROL MALEATE (POWDER - INHALATION), [NOVARTIS]
  383. ARIKAYCE KIT, AMIKACIN SULFATE (SUSPENSION, LIPOSOMAL - INHALATION), [INSMED INC]
  384. Aripiprazole (For Suspension, Extended Release - Intramuscular)
  385. Aripiprazole Lauroxil (Suspension, Extended Release - Intramuscular)
  386. Aripiprazole (Suspension, Extended Release - Intramuscular)
  387. Aripiprazole (Tablet - Oral)
  388. Aripiprazole (Tablet - Oral)
  389. Aripiprazole (Tablet, Orally Disintegrating - Oral)
  390. A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers…
  391. ARISTADA, ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE - INTRAMUSCULAR), [ALKERMES…
  392. ARISTADA INITIO KIT, ARIPIPRAZOLE LAUROXIL (SUSPENSION, EXTENDED RELEASE - INTRAMUSCULAR)…
  393. Armodafinil (Tablet - Oral)
  394. Arsenic Trioxide (Injection - Injectable)
  395. Artemether;Lumefantrine (Tablet - Oral)
  396. Artesunate (Powder - Intravenous)
  397. Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification…
  398. ARTHROTEC, DICLOFENAC SODIUM - MISOPROSTOL (TABLET, DELAYED RELEASE - ORAL), [PFIZER]
  399. Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and…
  400. ARYMO ER, MORPHINE SULFATE (TABLET, EXTENDED RELEASE - ORAL), [ZYLA]
  401. Asciminib Hydrochloride (Tablet - Oral)
  402. Asenapine Maleate (Tablet - Sublingual)
  403. Asenapine (System - Transdermal)
  404. Aspirin; Butalbital; Caffeine (Capsule - Oral)
  405. Aspirin; Butalbital; Caffeine; Codeine Phosphate (Capsule - Oral)
  406. Aspirin; Butalbital; Caffeine; Codeine Phosphate (Capsule - Oral)
  407. Aspirin; Butalbital; Caffeine (Tablet - Oral)
  408. Aspirin (Capsule, Extended Release - Oral)
  409. Aspirin (Capsule - Oral)
  410. Aspirin (Capsule - Oral)
  411. Aspirin; Dipyridamole (Capsule, Extended Release - Oral)
  412. Aspirin; Omeprazole (Tablet, Delayed Release - Oral)
  413. Aspirin; Oxycodone Hydrochloride; Aspirin;Oxycodone Terephthalate (Tablet - Oral)
  414. Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA…
  415. Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance…
  416. Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs: Guidance for…
  417. Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft…
  418. Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in…
  419. Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or…
  420. Assessing the Credibility of Computational Modeling and Simulation in Medical Device…
  421. Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology…
  422. Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery…
  423. Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for…
  424. Assessing User Fees Under the Biosimilar User Fee Amendments of 2022: Guidance for…
  425. Assessing User Fees Under the Generic Drug User Fee Amendments of 2017
  426. Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for…
  427. Assessing User Fees Under the Generic Drug User Fee Amendments of 2022
  428. Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program
  429. Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for…
  430. Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022
  431. Assessment of Abuse Potential of Drugs
  432. Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug…
  433. Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for…
  434. Assessment of Pressor Effects of Drugs Guidance for Industry: Draft Guidance for Industry
  435. Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment…
  436. ASTAGRAF XL, TACROLIMUS (CAPSULE, EXTENDED RELEASE - ORAL), [ASTELLAS]
  437. Atazanavir Sulfate (Capsule - Oral)
  438. Atazanavir Sulfate (Capsule - Oral)
  439. Atazanavir Sulfate; Cobicistat (Tablet - Oral)
  440. Atazanavir Sulfate; Cobicistat (Tablet - Oral)
  441. ATELVIA, RISEDRONATE SODIUM (TABLET, DELAYED RELEASE - ORAL), [APIL]
  442. Atenolol; Chlorthalidone (Tablet - Oral)
  443. Atenolol; Chlorthalidone (Tablet - Oral)
  444. Atenolol (Tablet - Oral)
  445. Atenolol (Tablet - Oral)
  446. ATIVAN, LORAZEPAM (TABLET - ORAL), [BAUSCH]
  447. Atogepant (Tablet - Oral)
  448. Atomoxetine Hydrochloride (Capsule - Oral)
  449. Atomoxetine Hydrochloride (Capsule - Oral)
  450. Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs
  451. Atorvastatin Calcium;Ezetimibe (Tablet - Oral)
  452. Atorvastatin Calcium; Ezetimibe (Tablet - Oral)
  453. Atorvastatin Calcium (Suspension - Oral)
  454. Atorvastatin Calcium (Tablet - Oral)
  455. Atorvastatin Calcium (Tablet - Oral)
  456. Atovaquone;Proguanil Hydrochloride (Tablet - Oral)
  457. Atovaquone (Suspension - Oral)
  458. Atovaquone (Suspension - Oral)
  459. Atovaquone (Tablet - Oral)
  460. Atovaquone (Tablet - Oral)
  461. Atropine Sulfate;Diphenoxylate Hydrochloride (Tablet - Oral)
  462. Atropine Sulfate (Solution/Drops - Ophthalmic)
  463. Atropine Sulfate (Solution/Drops - Ophthalmic)
  464. Attachement - Qualification Process for Drug Development Tools: Qualification of…
  465. Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment…
  466. AUBAGIO, TERIFLUNOMIDE (TABLET - ORAL), [SANOFI AVENTIS US]
  467. Auranofin (Capsule - Oral)
  468. Auranofin (Capsule - Oral)
  469. AUSTEDO, DEUTETRABENAZINE (TABLET - ORAL), [TEVA BRANDED PHARM]
  470. AUSTEDO, DEUTETRABENAZINE (TABLET - ORAL), [TEVA NEUROSCIENCE]
  471. AUVELITY, BUPROPION - DEXTROMETHORPHAN (TABLET, EXTENDED RELEASE - ORAL), [AXSOME INC]
  472. Avacopan (Capsule - Oral)
  473. Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood…
  474. Avanafil (Tablet - Oral)
  475. Avanafil (Tablet - Oral)
  476. AVANDAMET, METFORMIN HYDROCHLORIDE - ROSIGLITAZONE MALEATE (TABLET - ORAL), [SB PHARMCO]
  477. AVANDARYL, GLIMEPIRIDE - ROSIGLITAZONE MALEATE (TABLET - ORAL), [SB PHARMCO]
  478. AVANDIA, ROSIGLITAZONE MALEATE (TABLET - ORAL), [WOODWARD]
  479. Avapritinib (Tablet - Oral)
  480. Avatrombopag Maleate (Tablet - Oral)
  481. AVEED, TESTOSTERONE UNDECANOATE (INJECTABLE - INTRAMUSCULAR), [ENDO PHARMS INC]
  482. AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE (SOLUTION…
  483. AVELOX, MOXIFLOXACIN HYDROCHLORIDE (TABLET - ORAL), [BAYER HLTHCARE]
  484. AVINZA, MORPHINE SULFATE (CAPSULE, EXTENDED RELEASE - ORAL), [KING PHARMS LLC]
  485. AVONEX, INTERFERON BETA-1A (VIAL), [BIOGEN]
  486. AVSOLA, INFLIXIMAB-AXXQ (INJECTABLE - INJECTION), [AMGEN INC]
  487. AVTOZMA, TOCILIZUMAB-ANOH (INJECTABLE - INTRAVENOUS, SUBCUTANEOUS), [CELLTRION]
  488. AXIRON, TESTOSTERONE (SOLUTION, METERED - TRANSDERMAL), [ELI LILLY AND CO]
  489. Axitinib (Tablet - Oral)
  490. Axitinib (Tablet - Oral)
  491. Azacitidine (Powder - Intravenous, Subcutaneous)
  492. Azacitidine (Tablet - Oral)
  493. Azathioprine (Tablet - Oral)
  494. Azelaic Acid (Aerosol, Foam - Topical)
  495. Azelaic Acid (Cream - Topical)
  496. Azelaic Acid (Cream - Topical)
  497. Azelaic Acid (Gel - Topical)
  498. Azelaic Acid (Gel - Topical)
  499. Azelastine Hydrochloride; Fluticasone Propionate (Spray, Metered - Nasal)
  500. Azelastine Hydrochloride (Spray, Metered - Nasal)
  501. Azelastine Hydrochloride (Spray, Metered - Nasal)
  502. Azilsartan Kamedoxomil; Chlorthalidone (Tablet - Oral)
  503. Azilsartan Kamedoxomil; Chlorthalidone (Tablet - Oral)
  504. Azilsartan Kamedoxomil (Tablet - Oral)
  505. Azilsartan Kamedoxomil (Tablet - Oral)
  506. Azithromycin (For Suspension - Oral)
  507. Azithromycin (For Suspension - Oral)
  508. Azithromycin (For Suspension - Oral)
  509. Azithromycin (Suspension, Extended Release - Oral)
  510. Azithromycin (Tablet - Oral)
  511. Azithromycin (Tablet - Oral)
  512. AZSTARYS, DEXMETHYLPHENIDATE HYDROCHLORIDE - SERDEXMETHYLPHENIDATE CHLORIDE (CAPSULE…
  513. Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs…
  514. Bacitracin (Ointment - Ophthalmic)
  515. Baclofen (Granules - Oral)
  516. Baclofen (Suspension - Oral)
  517. Baclofen (Tablet - Oral)
  518. Baclofen (Tablet - Oral)
  519. Baclofen (Tablet, Orally Disintegrating - Oral)
  520. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion…
  521. Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry
  522. Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket…
  523. Balloon Valvuloplasty Guidance For The Submission Of an IDE Application and a PMA…
  524. Baloxavir Marboxil (For Suspension - Oral)
  525. Baloxavir Marboxil (Tablet - Oral)
  526. Balsalazide Disodium (Capsule - Oral)
  527. Balsalazide Disodium (Tablet - Oral)
  528. BANZEL, RUFINAMIDE (SUSPENSION - ORAL), [EISAI INC]
  529. BANZEL, RUFINAMIDE (TABLET - ORAL), [EISAI INC]
  530. Baricitinib (Tablet - Oral)
  531. Barium Sulfate (Paste - Oral)
  532. Barium Sulfate (Suspension - Oral)
  533. Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical…
  534. Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical…
  535. BAVENCIO, AVELUMAB (INJECTABLE - INJECTION), [EMD SERONO INC]
  536. BAVENCIO, AVELUMAB (INJECTABLE - INTRAVENOUS), [EMD SERONO INC]
  537. BAXDELA, DELAFLOXACIN MEGLUMINE (POWDER - INTRAVENOUS), [MELINTA]
  538. BAXDELA, DELAFLOXACIN MEGLUMINE (TABLET - ORAL), [MELINTA]
  539. Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems (Laser Notice…
  540. Beclomethasone Dipropionate (Aerosol, Metered - Inhalation)
  541. Beclomethasone Dipropionate (Aerosol, Metered - Nasal)
  542. Beclomethasone Dipropionate Monohydrate (Spray, Metered - Nasal)
  543. Bedaquiline Fumarate (Tablet - Oral)
  544. Bedaquiline Fumarate (Tablet - Oral)
  545. BELBUCA, BUPRENORPHINE HYDROCHLORIDE (FILM - BUCCAL), [BDSI]
  546. BELSOMRA, SUVOREXANT (TABLET - ORAL), [MERCK SHARP DOHME]
  547. Belumosudil Mesylate (Tablet - Oral)
  548. Belzutifan (Tablet - Oral)
  549. Bempedoic Acid; Ezetimibe (Tablet - Oral)
  550. Bempedoic Acid (Tablet - Oral)
  551. Benazepril Hydrochloride; Hydrochlorothiazide (Tablet - Oral)
  552. Benazepril Hydrochloride; Hydrochlorothiazide (Tablet - Oral)
  553. Benazepril Hydrochloride (Tablet - Oral)
  554. Benazepril Hydrochloride (Tablet - Oral)
  555. Benefit-Risk Assessment for New Drug and Biological Products
  556. Benefit-Risk Considerations for Product Quality Assessments
  557. Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket…
  558. BENLYSTA, BELIMUMAB (INJECTABLE - INJECTION), [GLAXOSMITHKLINE LLC]
  559. BENLYSTA, BELIMUMAB (INJECTABLE - INJECTION), [HUMAN GENOME SCIENCES INC.]
  560. Benoxinate hydrochloride; Fluorescein sodium (Solution/Drops - Topical)
  561. Benznidazole (Tablet - Oral)
  562. Benznidazole (Tablet - Oral)
  563. Benzonatate (Capsule - Oral)
  564. Benzoyl Peroxide; Clindamycin Phosphate (Gel - Topical)
  565. Benzoyl Peroxide; Erythromycin (Gel - Topical)
  566. Benzphetamine Hydrochloride (Tablet - Oral)
  567. Benztropine Mesylate (Tablet - Oral)
  568. Benzyl Alcohol (Lotion - Topical)
  569. Berotralstat Hydrochloride (Capsule - Oral)
  570. Besifloxacin Hydrochloride (Suspension/Drops - Ophthalmic)
  571. BESREMI, ROPEGINTERFERON ALFA-2B-NJFT (INJECTABLE - SUBCUTANEOUS), [PHARMAESSENTIA CORP]
  572. Best Practices for Communication Between IND Sponsors and FDA During Drug Development
  573. Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using…
  574. Best Practices for Selecting a Predicate Device to Support a Premarket Notification…
  575. Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products…
  576. Best Practices in Developing Proprietary Names for Human Prescription Drug Products…
  577. Betamethasone Acetate; Betamethasone Sodium Phosphate (Injectable - Injection)
  578. Betamethasone Dipropionate; Calcipotriene (Aerosol, Foam - Topical)
  579. Betamethasone Dipropionate; Calcipotriene (Cream - Topical)
  580. Betamethasone Dipropionate; Calcipotriene (Ointment - Topical)
  581. Betamethasone Dipropionate; Calcipotriene (Suspension - Topical)
  582. Betamethasone Dipropionate; Clotrimazole (Cream - Topical)
  583. Betamethasone Dipropionate; Clotrimazole (Lotion - Topical)
  584. Betamethasone dipropionate (Cream, Augmented - Topical)
  585. Betamethasone dipropionate (Cream - Topical)
  586. Betamethasone dipropionate (Lotion, Augmented - Topical)
  587. Betamethasone dipropionate (Lotion - Topical)
  588. Betamethasone dipropionate (Ointment, Augmented - Topical)
  589. Betamethasone dipropionate (Spray - Topical)
  590. Betamethasone Valerate (Aerosol, Foam - Topical)
  591. Betamethasone Valerate (Cream - Topical)
  592. Betamethasone Valerate (Lotion - Topical)
  593. Betamethasone Valerate (Ointment - Topical)
  594. BETASERON, INTERFERON BETA-1B (VIAL - SUBCUTANEOUS), [BAYER HEALTHCARE PHARMS]
  595. Betaxolol Hydrochloride (Solution/Drops - Ophthalmic)
  596. Bethanechol Chloride (Tablet - Oral)
  597. Betrixaban (Capsule - Oral)
  598. BEVYXXA, BETRIXABAN (CAPSULE - ORAL), [PORTOLA PHARMS INC]
  599. Bexagliflozin (Tablet - Oral)
  600. Bexarotene (Capsule - Oral)
  601. Bexarotene (Gel - Topical)
  602. Bicalutamide (Tablet - Oral)
  603. Bicalutamide (Tablet - Oral)
  604. Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate (Tablet - Oral)
  605. Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate (Tablet - Oral)
  606. Bimatoprost (Implant - Ophthalmic)
  607. Bimatoprost (Solution/Drops - Ophthalmic)
  608. Bimatoprost (Solution/Drops - Topical)
  609. BIMZELX, BIMEKIZUMAB-BKZX (INJECTABLE - SUBCUTANEOUS), [UCB INC]
  610. Binimetinib (Tablet - Oral)
  611. BINOSTO, ALENDRONATE SODIUM (TABLET, EFFERVESCENT - ORAL), [ASCEND THERAPS US]
  612. Bioanalytical Method Validation for Biomarkers
  613. Bioanalytical Method Validation Guidance for Industry
  614. Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local…
  615. Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General…
  616. Bioavailability Studies Submitted in NDAs or INDs – General Considerations
  617. Biocompatibility Testing of Medical Devices - Standards Specific Information for the…
  618. Biocompatibility Testing of Medical Devices - Standards Specific Information for the…
  619. Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an…
  620. Biological Indicator (BI) Premarket Notification [510(k)] Submissions : Guidance for…
  621. Biological Product Deviation Reporting for Blood and Plasma Establishments: Guidance for…
  622. Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products…
  623. Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff
  624. Bioresearch Monitoring Technical Conformance Guide
  625. Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure…
  626. Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and…
  627. Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of…
  628. Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium…
  629. Bismuth Subcitrate Potassium; Metronidazole;Tetracycline Hydrochloride (Capsule - Oral)
  630. Bismuth Subsalicylate; Metronidazole; Tetracycline Hydrochloride (Tablet, Chewable…
  631. Bisoprolol Fumarate; Hydrochlorothiazide (Tablet - Oral)
  632. Bisoprolol Fumarate; Hydrochlorothiazide (Tablet - Oral)
  633. Bisoprolol Fumarate (Tablet - Oral)
  634. Bisoprolol Fumarate (Tablet - Oral)
  635. Bispecific Antibody Development Programs Guidance for Industry
  636. Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment: Guidance for…
  637. BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood…
  638. BLENREP, BELANTAMAB MAFODOTIN-BLMF (INJECTABLE - INTRAVENOUS), [GLAXOSMITHKLINE]
  639. BLINCYTO, BLINATUMOMAB (INJECTABLE - INJECTION), [AMGEN]
  640. Blood Establishment Computer System Validation in the User's Facility: Guidance for…
  641. Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Guidance for…
  642. Blood Lancet Labeling - Guidance for Industry and Food and Drug Administration Staff
  643. Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for…
  644. Boceprevir (Capsule - Oral)
  645. Boceprevir (Capsule - Oral)
  646. Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food…
  647. BONIVA, IBANDRONATE SODIUM (INJECTABLE - INTRAVENOUS), [ROCHE]
  648. BONIVA, IBANDRONATE SODIUM (TABLET - ORAL), [HOFFMANN LA ROCHE]
  649. BONSITY, TERIPARATIDE (SOLUTION - SUBCUTANEOUS), [ALVOGEN]
  650. Bortezomib (Injectable - Intravenous, Subcutaneous)
  651. Bosentan (Tablet, For Suspension - Oral)
  652. Bosentan (Tablet, For Suspension - Oral)
  653. Bosentan (Tablet - Oral)
  654. Bosentan (Tablet - Oral)
  655. Bosutinib Monohydrate (Tablet - Oral)
  656. Botanical Drug Development: Guidance for Industry
  657. BOTOX COSMETIC, OnabotulinumtoxinA (VIAL - SINGLE-USE), [ALLERGAN]
  658. BOTOX, OnabotulinumtoxinA (VIAL - SINGLE-USE), [ALLERGAN]
  659. Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New…
  660. BRAFTOVI, ENCORAFENIB (CAPSULE - ORAL), [ARRAY BIOPHARMA INC]
  661. Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff
  662. Breast Implants - Certain Labeling Recommendations to Improve Patient Communication…
  663. Bremelanotide Acetate (Solution - Subcutaneous)
  664. BRENZAVVY, BEXAGLIFLOZIN (TABLET - ORAL), [THERACOS BIO]
  665. BREXAFEMME, IBREXAFUNGERP (TABLET - ORAL), [SCYNEXIS]
  666. Brexanolone (Solution - Intravenous)
  667. Brexpiprazole (Tablet - Oral)
  668. Brexpiprazole (Tablet - Oral)
  669. Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for…
  670. Brief Summary and Adequate Directions for Use: Disclosing Risk Information in…
  671. Brigatinib (Tablet - Oral)
  672. BRILINTA, TICAGRELOR (TABLET - ORAL), [ASTRAZENECA]
  673. Brilliant Blue G (Solution - Ophthalmic)
  674. Brimonidine Tartrate; Brinzolamide (Suspension/Drops - Ophthalmic)
  675. Brimonidine Tartrate (Gel - Topical)
  676. Brimonidine Tartrate (Solution/Drops 0.15% - Ophthalmic)
  677. Brimonidine Tartrate (Solution/Drops 0.1% - Ophthalmic)
  678. Brimonidine Tartrate (Solution/Drops 0.2% - Ophthalmic)
  679. Brimonidine Tartrate (Solution/Drops - Ophthalmic)
  680. Brimonidine Tartrate;Timolol Maleate (Solution/Drops - Ophthalmic)
  681. Brincidofovir (Suspension - Oral)
  682. Brincidofovir (Tablet - Oral)
  683. Brinzolamide (Suspension/Drops 1% - Ophthalmic)
  684. BRISDELLE, PAROXETINE MESYLATE (CAPSULE - ORAL), [SEBELA IRELAND LTD]
  685. BRIUMVI, UBLITUXIMAB-XIIY (INJECTABLE - INJECTION), [TG Therapeutics]
  686. Brivaracetam (Tablet - Oral)
  687. Brivaracetam (Tablet - Oral)
  688. BRIVIACT, BRIVARACETAM (SOLUTION - INTRAVENOUS), [UCB INC]
  689. BRIVIACT, BRIVARACETAM (SOLUTION - ORAL), [UCB INC]
  690. BRIVIACT, BRIVARACETAM (TABLET - ORAL), [UCB INC]
  691. BRIXADI, BUPRENORPHINE (INJECTION, EXTENDED RELEASE - SUBCUTANEOUS), [BRAEBURN]
  692. Bromfenac Sodium (Solution/Drops - Ophthalmic)
  693. Bromocriptine Mesylate (Capsule - Oral)
  694. Bromocriptine Mesylate (Tablet - Oral)
  695. Bromocriptine mesylate (Tablet - Oral)
  696. BROVANA, ARFORMOTEROL TARTRATE (SOLUTION - INHALATION), [SUNOVION]
  697. BRYNOVIN, SITAGLIPTIN (SOLUTION - ORAL), [AZURITY PHARMACEUTICALS, INC]
  698. Budesonide (Aerosol, Foam - Rectal)
  699. Budesonide (Capsule, Delayed Release - Oral)
  700. Budesonide (Capsule, Delayed Release - Oral)
  701. Budesonide (Capsule, Extended Release - Oral)
  702. Budesonide; Formoterol Fumarate Dihydrate (Aerosol, Metered - Inhalation)
  703. Budesonide; Formoterol Fumarate; Glycopyrrolate (Aerosol, Metered - Inhalation)
  704. Budesonide (Powder, Metered - Inhalation)
  705. Budesonide (Spray, Metered - Nasal)
  706. Budesonide (Suspension - Inhalation)
  707. Budesonide (Tablet, Extended Release - Oral)
  708. Bumetanide (Tablet - Oral)
  709. Bumetanide (Tablet - Oral)
  710. BUNAVAIL, BUPRENORPHINE HYDROCHLORIDE - NALOXONE HYDROCHLORIDE (FILM - BUCCAL), [BDSI]
  711. Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for…
  712. Bupivacaine (Injectable, Liposomal - Injection)
  713. Bupivacaine (Solution, Extended Release - Infiltration)
  714. Buprenorphine (Film, Extended Release - Transdermal)
  715. Buprenorphine Hydrochloride (Film - Buccal)
  716. Buprenorphine Hydrochloride; Naloxone Hydrochloride (Film - Buccal)
  717. Buprenorphine Hydrochloride; Naloxone Hydrochloride (Film - Buccal, Sublingual)
  718. Buprenorphine Hydrochloride; Naloxone Hydrochloride (Tablet - Sublingual)
  719. Buprenorphine Hydrochloride; Naloxone Hydrochloride (Tablet - Sublingual)
  720. Buprenorphine Hydrochloride (Tablet - Sublingual)
  721. Buprenorphine (Solution, Extended Release - Subcutaneous)
  722. Bupropion Hydrobromide (Tablet, Extended Release - Oral)
  723. Bupropion Hydrochloride; Naltrexone Hydrochloride (Tablet, Extended Release - Oral)
  724. Bupropion Hydrochloride (Tablet, Extended Release - Oral)
  725. Bupropion Hydrochloride (Tablet, Extended Release - Oral)
  726. Bupropion Hydrochloride (Tablet - Oral)
  727. Bupropion Hydrochloride (Tablet - Oral)
  728. Buspirone Hydrochloride (Capsule - Oral)
  729. Buspirone Hydrochloride (Tablet - Oral)
  730. Buspirone Hydrochloride (Tablet - Oral)
  731. Busulfan (Tablet - Oral)
  732. Butenafine Hydrochloride (Cream - Topical)
  733. Butoconazole Nitrate (Cream - Vaginal)
  734. BUTRANS, BUPRENORPHINE (FILM, EXTENDED RELEASE - TRANSDERMAL), [PURDUE PHARMA LP]
  735. BYDUREON BCISE, EXENATIDE SYNTHETIC (SUSPENSION, EXTENDED RELEASE - SUBCUTANEOUS)…
  736. BYDUREON, EXENATIDE SYNTHETIC (FOR SUSPENSION, EXTENDED RELEASE - SUBCUTANEOUS)…
  737. BYDUREON PEN, EXENATIDE SYNTHETIC (FOR SUSPENSION, EXTENDED RELEASE - SUBCUTANEOUS)…
  738. BYETTA, EXENATIDE SYNTHETIC (INJECTABLE - SUBCUTANEOUS), [AMYLIN]
  739. BYETTA, EXENATIDE SYNTHETIC (INJECTABLE - SUBCUTANEOUS), [ASTRAZENECA AB]
  740. Cabotegravir; Rilpivirine (Suspension, Extended Release - Intramuscular)
  741. Cabotegravir Sodium (Tablet - Oral)
  742. Cabotegravir (Suspension, Extended Release - Intramuscular)
  743. Cabozantinib S-Malate (Capsule - Oral)
  744. Cabozantinib S-Malate (Tablet - Oral)
  745. Caffeine; Ergotamine Tartrate (Suppository - Rectal)
  746. Calcifediol (Capsule, Extended Release - Oral)
  747. Calcipotriene (Aerosol, Foam - Topical)
  748. Calcipotriene (Cream - Topical)
  749. Calcipotriene (Ointment - Topical)
  750. Calcipotriene (Solution - Topical)
  751. Calcitonin Salmon (Injectable - Injection)
  752. Calcitonin Salmon (Spray, Metered - Nasal)
  753. Calcitriol (Capsule - Oral)
  754. Calcium Acetate (Capsule - Oral)
  755. Calcium Acetate (Tablet - Oral)
  756. Calcium Carbonate; Famotidine; Magnesium Hydroxide (Tablet, Chewable - Oral)
  757. Calcium Carbonate;Risedronate Sodium (Tablet, Tablet - Oral)
  758. Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application
  759. CAMBIA, DICLOFENAC POTASSIUM (FOR SOLUTION - ORAL), [ASSERTIO]
  760. CAMZYOS, MAVACAMTEN (CAPSULE - ORAL), [BRISTOL MYERS SQUIBB]
  761. Canagliflozin; Metformin Hydrochloride (Tablet, Extended Release - Oral)
  762. Canagliflozin; Metformin Hydrochloride (Tablet - Oral)
  763. Canagliflozin; Metformin Hydrochloride (Tablet - Oral)
  764. Canagliflozin (Tablet - Oral)
  765. Canagliflozin (Tablet - Oral)
  766. Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings…
  767. Cancer Clinical Trial Eligibility Criteria: Brain Metastases
  768. Cancer Clinical Trial Eligibility Criteria: Laboratory Values: Guidance for Industry…
  769. Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of…
  770. Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or…
  771. Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or…
  772. Cancer Clinical Trial Eligibility Criteria: Performance Status: Guidance for Industry…
  773. Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications…
  774. Cancer Drug and Biological Products - Clinical Data in Marketing Applications
  775. Candesartan Cilexetil; Hydrochlorothiazide (Tablet - Oral)
  776. Candesartan Cilexetil; Hydrochlorothiazide (Tablet - Oral)
  777. Candesartan Cilexetil (Tablet - Oral)
  778. Candesartan Cilexetil (Tablet - Oral)
  779. Cannabidiol (Solution - Oral)
  780. Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research…
  781. Cantharidin (Solution - Topical)
  782. Capecitabine (Tablet - Oral)
  783. CAPLYTA, LUMATEPERONE TOSYLATE (CAPSULE - ORAL), [INTRA-CELLULAR]
  784. Capmatinib Hydrochloride (Tablet - Oral)
  785. CAPRELSA, VANDETANIB (TABLET - ORAL), [GENZYME CORP]
  786. Capsaicin (Patch - Topical)
  787. Captopril (Tablet - Oral)
  788. Carbamazepine (Capsule, Extended Release - Oral)
  789. Carbamazepine (Suspension - Oral)
  790. Carbamazepine (Tablet, Chewable - Oral)
  791. Carbamazepine (Tablet, Extended Release - Oral)
  792. Carbamazepine (Tablet - Oral)
  793. CARBATROL, CARBAMAZEPINE (CAPSULE, EXTENDED RELEASE - ORAL), [TAKEDA PHARMS USA]
  794. Carbidopa; Entacapone; Levodopa (Tablet - Oral)
  795. Carbidopa; Entacapone; Levodopa (Tablet - Oral)
  796. Carbidopa; Levodopa (Capsule, Extended Release - Oral)
  797. Carbidopa; Levodopa (Suspension - Enteral)
  798. Carbidopa; Levodopa (Tablet, Extended Release - Oral)
  799. Carbidopa; Levodopa (Tablet - Oral)
  800. Carbidopa; Levodopa (Tablet - Oral)
  801. Carbidopa; Levodopa (Tablet, Orally Disintegrating - Oral)
  802. Carbidopa (Tablet - Oral)
  803. Carbidopa (Tablet - Oral)
  804. Carbinoxamine Maleate (Suspension, Extended Release - Oral)
  805. Carbinoxamine Maleate (Tablet - Oral)
  806. Carcinogenicity Study Protocol Submissions
  807. Cardiac Ablation Catheters Generic Arrhythmia Indications for Use - Guidance for Industry
  808. Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm) - Guidance for…
  809. Carglumic Acid (Tablet, For Suspension - Oral)
  810. Cariprazine Hydrochloride (Capsule - Oral)
  811. Carisoprodol (Tablet - Oral)
  812. Carisoprodol (Tablet - Oral)
  813. Carvedilol Phosphate (Capsule, Extended Release - Oral)
  814. Carvedilol Phosphate (Capsule, Extended Release - Oral)
  815. Carvedilol (Tablet - Oral)
  816. Carvedilol (Tablet - Oral)
  817. Casimersen (Solution - Intravenous)
  818. Caspofungin Acetate (Powder - Intravenous)
  819. CASSIPA, BUPRENORPHINE HYDROCHLORIDE - NALOXONE HYDROCHLORIDE (FILM - SUBLINGUAL), [TEVA…
  820. CATAFLAM, DICLOFENAC POTASSIUM (TABLET - ORAL), [NOVARTIS]
  821. CDER’s Program for the Recognition of Voluntary Consensus Standards Related to…
  822. Cedazuridine; Decitabine (Tablet - Oral)
  823. Cefaclor (Capsule - Oral)
  824. Cefaclor (Capsule - Oral)
  825. Cefaclor (Tablet, Extended Release - Oral)
  826. Cefadroxil; Cefadroxil Hemihydrate (Capsule - Oral)
  827. Cefadroxil; Cefadroxil Hemihydrate (Capsule - Oral)
  828. Cefazolin Sodium (Powder - Intravenous)
  829. Cefdinir (Capsule - Oral)
  830. Cefdinir (Capsule - Oral)
  831. Cefdinir (For Suspension - Oral)
  832. Cefdinir (Powder For Suspension - Oral)
  833. Cefditoren Pivoxil (Tablet - Oral)
  834. Cefditoren Pivoxil (Tablet - Oral)
  835. Cefiderocol Sulfate Tosylate (Powder - Intravenous)
  836. Cefixime (Capsule - Oral)
  837. Cefixime (Capsule - Oral)
  838. Cefixime (For Suspension - Oral)
  839. Cefixime (Suspension - Oral)
  840. Cefixime (Tablet, Chewable - Oral)
  841. Cefixime (Tablet, Chewable - Oral)
  842. Cefixime (Tablet - Oral)
  843. Cefixime (Tablet - Oral)
  844. Cefpodoxime Proxetil (For Suspension - Oral)
  845. Cefpodoxime Proxetil (Suspension - Oral)
  846. Cefpodoxime Proxetil (Tablet - Oral)
  847. Cefpodoxime Proxetil (Tablet - Oral)
  848. Cefprozil (For Suspension - Oral)
  849. Cefprozil (Suspension - Oral)
  850. Cefprozil (Tablet - Oral)
  851. Cefprozil (Tablet - Oral)
  852. Cefuroxime Axetil (For Suspension - Oral)
  853. Cefuroxime Axetil (Suspension - Oral)
  854. Cefuroxime Axetil (Tablet - Oral)
  855. Cefuroxime Axetil (Tablet - Oral)
  856. CELEBREX, CELECOXIB (CAPSULE - ORAL), [GD SEARLE LLC]
  857. CELEBREX, CELECOXIB (CAPSULE - ORAL), [UPJOHN]
  858. Celecoxib (Capsule - Oral)
  859. Celecoxib; Tramadol Hydrochloride (Tablet - Oral)
  860. CELEXA, CITALOPRAM HYDROBROMIDE (SOLUTION - ORAL), [FOREST LABS]
  861. CELEXA, CITALOPRAM HYDROBROMIDE (TABLET - ORAL), [ALLERGAN]
  862. Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet
  863. CELLCEPT, MYCOPHENOLATE MOFETIL (CAPSULE - ORAL), [ROCHE PALO]
  864. CELLCEPT, MYCOPHENOLATE MOFETIL (FOR SUSPENSION - ORAL), [ROCHE PALO]
  865. CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE (INJECTABLE - INJECTION), [ROCHE PALO]
  866. CELLCEPT, MYCOPHENOLATE MOFETIL (TABLET - ORAL), [ROCHE PALO]
  867. Cellular Therapy for Cardiac Disease: Guidance for Industry
  868. CELONTIN, METHSUXIMIDE (CAPSULE - ORAL), [PARKE DAVIS]
  869. Cenobamate (Tablet - Oral)
  870. Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry…
  871. Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers…
  872. Cephalexin (Capsule - Oral)
  873. Cephalexin (Capsule - Oral)
  874. Cephalexin (For Suspension - Oral)
  875. Cephalexin (Suspension - Oral)
  876. CERDELGA, ELIGLUSTAT TARTRATE (CAPSULE - ORAL), [GENZYME CORP]
  877. Ceritinib (Capsule - Oral)
  878. Ceritinib (Capsule - Oral)
  879. Ceritinib (Tablet - Oral)
  880. Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered…
  881. Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9)
  882. Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for…
  883. Certain Postapproval Requirements and Resources for ANDAs
  884. Certificates of Confidentiality: Guidance for Sponsors, Sponsor-Investigators…
  885. Certification Process for Designated Medical Gases: Draft Guidance for Industry
  886. Cetirizine Hydrochloride (Capsule - Oral)
  887. Cetirizine Hydrochloride (Capsule - Oral)
  888. Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride (Tablet, Extended Release - Oral)
  889. Cetirizine Hydrochloride (Tablet, Chewable - Oral)
  890. Cetirizine Hydrochloride (Tablet - Oral)
  891. Cetirizine Hydrochloride (Tablet - Oral)
  892. Cetirizine Hydrochloride (Tablet, Orally Disintegrating - Oral)
  893. Cevimeline Hydrochloride (Capsule - Oral)
  894. Cevimeline Hydrochloride (Capsule - Oral)
  895. CGO Sec 540.275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving…
  896. Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance…
  897. Changes to an Approved Application: Biological Products: Guidance for Industry
  898. Changes to an Approved Application: Biological Products: Human Blood and Blood Components…
  899. Changes to an Approved Application for Specified Biotechnology and Specified Synthetic…
  900. Changes to an Approved NDA or ANDA: Guidance for Industry
  901. Changes to an Approved NDA or ANDA: Questions and Answers: Guidance for Industry
  902. Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for…
  903. Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry
  904. Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st…
  905. CHANTIX, VARENICLINE TARTRATE (TABLET - ORAL), [PF PRISM CV]
  906. chapter-1-general-2019-02-09Chapter 1 - General
  907. Chapter 2 - Biologics
  908. chapter-3-devices-2022-04-22Chapter 3 - Devices
  909. Chapter 48 7348.809A Radioactive Drug Research Committee
  910. CHAPTER 48 - 7348.809 Bioresearch Monitoring
  911. Chapter 4 - Human Drugs
  912. Characterization and Qualification of Cell Substrates and Other Biological Materials Used…
  913. Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic…
  914. Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic…
  915. Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer…
  916. Charging for Investigational Drugs Under an IND: Questions and Answers
  917. Charging for Investigational Products: Guidance for Institutional Review Boards and…
  918. Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and…
  919. Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE)…
  920. Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for…
  921. Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy…
  922. Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain…
  923. Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and…
  924. Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention Guidance for…
  925. Chenodiol (Tablet - Oral)
  926. Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry
  927. Chinese Translation of Draft Guidance for Industry: Questions and Answers Regarding the…
  928. Chinese Translation of Guidance for Industry: Submitting a Report for Multiple Facilities…
  929. Chinese Translation of the Guidance for Industry: Questions and Answers Regarding the…
  930. Chlorambucil (Tablet - Oral)
  931. CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE…
  932. Chlordiazepoxide Hydrochloride (Capsule - Oral)
  933. Chlordiazepoxide Hydrochloride; Clidinium Bromide (Capsule - Oral)
  934. Chlordiazepoxide Hydrochloride; Clidinium Bromide (Capsule - Oral)
  935. Chlorhexidine Gluconate (Solution - Topical)
  936. Chlorhexidine Gluconate (Tablet - Dental)
  937. Chloroprocaine Hydrochloride (Gel - Ophthalmic)
  938. Chloroquine Phosphate (Tablet - Oral)
  939. Chlorothiazide (Suspension - Oral)
  940. Chlorothiazide (Suspension - Oral)
  941. Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride (Tablet - Oral)
  942. Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride (Tablet - Oral)
  943. Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride (Tablet - Oral)
  944. Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride (Tablet - Oral)
  945. Chlorpheniramine Maleate (Tablet, Extended Release - Oral)
  946. Chlorpheniramine Polistirex; Codeine Polistirex (Suspension, Extended Release - Oral)
  947. Chlorpheniramine Polistirex; Hydrocodone Polistirex (Capsule, Extended Release - Oral)
  948. Chlorpheniramine Polistirex; Hydrocodone Polistirex (Suspension, Extended Release - Oral)
  949. Chlorpromazine Hydrochloride (Concentrate - Oral)
  950. Chlorpromazine Hydrochloride (Tablet - Oral)
  951. Chlorpromazine Hydrochloride (Tablet - Oral)
  952. Chlorthalidone (Tablet - Oral)
  953. Chlorzoxazone (Tablet 500 mg - Oral)
  954. Chlorzoxazone (Tablet 750 mg - Oral)
  955. Chlorzoxazone (Tablet - Oral)
  956. Cholestyramine (Powder - Oral)
  957. Cholic Acid (Capsule - Oral)
  958. Cholic Acid (Capsule - Oral)
  959. Choline Fenofibrate (Capsule, Delayed Release - Oral)
  960. Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for Treatment
  961. Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment
  962. Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment
  963. Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for…
  964. Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry
  965. Chronic Obstructive Pulmonary Disease: Use of the St. George’s Respiratory Questionnaire…
  966. Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment : Guidance for…
  967. CIBINQO, ABROCITINIB (TABLET - ORAL), [PFIZER INC]
  968. Ciclesonide (Aerosol, Metered - Inhalation)
  969. Ciclesonide (Aerosol, Metered - Nasal)
  970. Ciclesonide (Spray, Metered - Nasal)
  971. Ciclopirox (Cream - Topical)
  972. Ciclopirox (Gel - Topical)
  973. Ciclopirox (Shampoo - Topical)
  974. Ciclopirox (Solution - Topical)
  975. Ciclopirox (Suspension - Topical)
  976. Cilastatin Sodium; Imipenem; Relebactam (Powder - Intravenous)
  977. Cilostazol (Tablet - Oral)
  978. Cimetidine (Tablet - Oral)
  979. CIMZIA, CERTOLIZUMAB PEGOL (INJECTABLE - INJECTION), [UCB INC]
  980. Cinacalcet Hydrochloride (Tablet - Oral)
  981. Cinacalcet Hydrochloride (Tablet - Oral)
  982. CIPRO, CIPROFLOXACIN (FOR SUSPENSION - ORAL), [BAYER HLTHCARE]
  983. CIPRO, CIPROFLOXACIN HYDROCHLORIDE (TABLET - ORAL), [BAYER HLTHCARE]
  984. CIPRO, CIPROFLOXACIN (INJECTABLE - INJECTION), [BAYER HLTHCARE]
  985. Ciprofloxacin; Ciprofloxacin Hydrochloride (Tablet, Extended Release - Oral)
  986. Ciprofloxacin; Dexamethasone (Suspension/Drops - Otic)
  987. Ciprofloxacin; Dexamethasone (Suspension/Drops - Otic)
  988. Ciprofloxacin (For Suspension - Oral)
  989. Ciprofloxacin Hydrochloride; Hydrocortisone (Suspension/Drops - Otic)
  990. Ciprofloxacin Hydrochloride; Hydrocortisone (Suspension/Drops - Otic)
  991. Ciprofloxacin hydrochloride (Ointment - Ophthalmic)
  992. Ciprofloxacin Hydrochloride (Solution/Drops - Ophthalmic)
  993. Ciprofloxacin Hydrochloride (Tablet, Extended Release - Oral)
  994. Ciprofloxacin Hydrochloride (Tablet - Oral)
  995. Ciprofloxacin Hydrochloride (Tablet - Oral)
  996. Ciprofloxacin (Suspension, Injectable - Otic)
  997. Ciprofloxacin (Suspension - Oral)
  998. CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN (INJECTABLE - INJECTION), [BAYER…
  999. CIPRO XR, CIPROFLOXACIN - CIPROFLOXACIN HYDROCHLORIDE (TABLET, EXTENDED RELEASE - ORAL)…
  1000. Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection…

About this dataset

FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.

Source: U.S. Food and Drug Administration (FDA), Guidance Documents