April 13, 2018
- CDER Alert: FDA alerts health care professionals to voluntary nationwide recall of all sterile products from Coastal Meds
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages
- Aminocaproic Acid Injection, USP (Updated - Currently in Shortage)
- Atropine Sulfate Injection (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage)
- Bupivacaine Hydrochloride Injection, USP (Updated - Currently in Shortage)
- Calcium Chloride Injection, USP (Updated - Currently in Shortage)
- Cefepime Injection (Updated - Currently in Shortage)
- Dextrose 5% Injection Bags (Updated - Currently in Shortage)
- Dextrose 50% Injection (Updated - Currently in Shortage)
- Diltiazem Hydrochloride (Updated - Currently in Shortage)
- Dobutamine Hydrochloride Injection (Updated - Currently in Shortage)
- Dopamine Hydrochloride Injection (Updated - Currently in Shortage)
- Epinephrine Injection, 0.1 mg/mL (Updated - Currently in Shortage)
- Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
- Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
- Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
- Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
- Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage)
- Methotrexate Sodium Injection (Updated - Updated - Currently in Shortage)
- Metronidazole Injection, USP (Updated - Currently in Shortage)
- Morphine Sulfate Injection, USP (Updated - Currently in Shortage)
- Pantoprazole (Protonix) Powder for Injection (Updated - Currently in Shortage)
- Penicillin G Benzathine and Penicillin G Procaine (Bicillin C-R) Injection (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)
- 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 Phosphate Injection (Updated - Currently in Shortage)
- Sterile Water (Updated - Currently in Shortage)
- Theophylline Extended Release Tablets and Capsules (Updated - Resolved)
- National Drug Code Directory (updated)
- Orange Book (updated)
- Orange Book Current Cumulative Supplement 2018 (PDF – 728KB) (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
- Orange Book Data Files (compressed) (ZIP - 698KB) (updated)
- Reference Listed Drugs by ANDA Reference Standard List (PDF - 91KB) (updated)
- Orange Book Patent Listing Dispute List (updated)
- Appendix A: Product Name Index (PDF - 168KB) (updated)
- Appendix B: Product Name Sorted by Applicant (PDF - 408KB) (updated)
- Appendix C: Uniform Terms (PDF - 24KB) (updated)
- Warning Letters 2018 (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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