November 17, 2017
- Novel Drug Approvals for 2017 (updated)
- Generic Drug User Fee Amendments - Program Fee List Files (updated)
- Purple Book: Lists of Licensed Biological Products (updated)
- CDER Warning Letters 2017 (Updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Cefotetan Disodium Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection Bags (Updated - Currently in Shortage)
- Disopyramide Phosphate (Norpace) Capsules (Updated - Currently in Shortage)
- Enalapril Maleate Tablets (New - Discontinuation)
- Folic Acid Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Methylprednisolone Sodium Succinate for Injection, USP (Updated - Currently in Shortage)
- Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
- Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Rocuronium Bromide Injection (Updated - Currently in Shortage)
- Sodium Acetate Injection, USP (Updated - Currently in Shortage)
- Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Phosphate Injection (Updated - Currently in Shortage)
- National Drug Code Directory (updated)
- Orange Book (updated)
- October 2017: Additions and Deletions to the Drug Product List (PDF - 146KB)
- Orange Book Data Files (compressed) (ZIP - 669KB)
- Orange Book Current Cumulative Supplement 2017 (PDF - 1.7MB)
- Orange Book Patent Listing Dispute List (PDF - 106KB)
- Reference Listed Drugs by ANDA Reference Standard List (PDF - 88KB)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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