Archived documents
Documents past their public comment period for FDA.
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PSG_020076 - Draft Guidance on Nicotine
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- Public health benefits of lower nicotine
Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information
1 comment
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- Pediatric and neonatal considerations
Notice of Filing Miles Laboratories, Inc.; Filing of A Petition for Affirmation of GRAS Status
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Food Additives Permitted for Direct Addition to Food for Human Consumption; Sucralose
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Determination That SERZONE (Nefazodone Hydrochloride) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness", also download published version into the folder.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That DIAZEPAM Injection United States Pharmacopeia (5 Milligrams/Milliliter in a 1- Milliliter Container) Was not Withdrawn From Sale for Reasons of Safety or Effectiveness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Determination That PYRIDOSTIGMINE BROMIDE Tablets, 30 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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"Determination That LOVENOX (Enoxaparin Sodium) 90 Milligrams/0.6 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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PSG_020503 - Draft Guidance on Albuterol Sulfate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PSG_214070 - Draft Guidance on Albuterol Sulfate; Budesonide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PSG_219423 - Draft Guidance on Amlodipine Besylate; Indapamide; Telmisartan
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