CDER New December 16, 2019

December 13, 2019

• Public Notification: PremierZEN Gold 7000 contains hidden drug ingredients
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Anagrelide Hydrochloride Capsules (Updated - Currently in Shortage)
  • Atropine Sulfate Injection (Updated - Currently in Shortage)
  • Atropine Sulfate Ophthalmic Ointment (Updated - Currently in Shortage)
  • Bumetanide Injection, USP (Updated - Currently in Shortage)
  • Cefoxitin for Injection, USP (Updated - Currently in Shortage)
  • Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
  • Diltiazem Hydrochloride (Updated - Currently in Shortage)
  • Dorzolamide Hydrochloride and Timolol Maleate (Cosopt) Ophthalmic Solution(Updated - Currently in Shortage)
  • Dorzolamide Hydrochloride Ophthalmic Solution (Updated - Currently in Shortage)
  • Enalaprilat Injection, USP (Updated - Currently in Shortage)
  • Epinephrine Injection, Auto-Injector (Updated - Currently in Shortage)
  • Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage)
  • Hydromorphone Hydrochloride Injection, USP (Updated - Currently in Shortage)
  • Hydroxyzine Pamoate Oral Capsules (Updated - Currently in Shortage)
  • Ketorolac Tromethamine Injection (Updated - Currently in Shortage)
  • Labetalol Hydrochloride Injection (Updated - Currently in Shortage)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Lorazepam Injection, USP (Updated - Currently in Shortage)
  • Methocarbamol Tablets (Updated - Resolved)
  • Methotrexate Sodium Injection (Updated - Currently in Shortage)
  • Morphine Sulfate Injection, USP (Currently in Shortage)
  • Mupirocin Calcium Nasal Ointment (Updated - Discontinuation)
  • Olmesartan Medoxomil Tablets (Updated - Currently in Shortage)
  • Pantoprazole Sodium for Injection (Updated - Currently in Shortage)
  • Promethazine (Phenergan) Injection (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
  • Valsartan Tablets (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Orange Book
  • Orange Book Current Cumulative Supplement (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)