Archived documents
Documents past their public comment period for Pharmaceutical Policy.
2026-10089
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Determination That SERZONE (Nefazodone Hydrochloride) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness", also download published version into the folder.
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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That DIAZEPAM Injection United States Pharmacopeia (5 Milligrams/Milliliter in a 1- Milliliter Container) Was not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Determination That PYRIDOSTIGMINE BROMIDE Tablets, 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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Letter from FDA CDER to Lachman Consultant Services, Inc.
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"Determination That LOVENOX (Enoxaparin Sodium) 90 Milligrams/0.6 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
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PSG_020503 - Draft Guidance on Albuterol Sulfate
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PSG_214070 - Draft Guidance on Albuterol Sulfate; Budesonide
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PSG_219423 - Draft Guidance on Amlodipine Besylate; Indapamide; Telmisartan
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PSG_210745 - Draft Guidance on Apremilast
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PSG_202971 - Draft Guidance on Aripiprazole
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PSG_218643 - Draft Guidance on Articaine Hydrochloride
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