Archived documents

FDAInterim Final Rule

Records and Reports Concerning Experience With Approved New Animal Drugs

FDANotice

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs

FDANotice

Pediatric Dosing with Over-the-Counter Drug Products; Summary Information Document for Advisory Committee Meeting; Availability; Establishment of a Public Docket and Request for Comments

FDANotice

Determination That SERZONE (Nefazodone Hydrochloride) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness", also download published version into the folder.

FDANotice

Determination That DIAZEPAM Injection United States Pharmacopeia (5 Milligrams/Milliliter in a 1- Milliliter Container) Was not Withdrawn From Sale for Reasons of Safety or Effectiveness

FDANotice

Determination That PYRIDOSTIGMINE BROMIDE Tablets, 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

FDAOther

Letter from FDA CDER to Lachman Consultant Services, Inc.

FDANotice

"Determination That LOVENOX (Enoxaparin Sodium) 90 Milligrams/0.6 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

FDAOther

PSG_020503 - Draft Guidance on Albuterol Sulfate

FDAOther

PSG_214070 - Draft Guidance on Albuterol Sulfate; Budesonide

FDAOther

PSG_219423 - Draft Guidance on Amlodipine Besylate; Indapamide; Telmisartan

FDAOther

PSG_210745 - Draft Guidance on Apremilast