August 20, 2018
- Pediatric Exclusivity Statistics (updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
- Calcium Gluconate Injection (Updated - Currently in Shortage)
- Cefotetan Disodium Injection (Updated - Currently in Shortage)
- Deferoxamine Mesylate for Injection, USP (Updated - Currently in Shortage)
- Dextrose 5% Injection Bags (Updated - Currently in Shortage)
- Etoposide Injection (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Magnesium Sulfate Injection (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Currently in Shortage)
- Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
- Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
- Potassium Chloride Injection (Updated - Currently in Shortage)
- Remifentanil (Ultiva) Lyophilized Powder for Solution Injection (Updated - Currently in Shortage)
- Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage)
- Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage)
- Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
- Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage)
- Sterile Water (Updated - Currently in Shortage)
- Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations (PDF - 83KB)
- National Drug Code Directory (updated)
- Quality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 169KB)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
- Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)
- FDA Update on Valsartan Recall (updated)
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