CDER New October 2, 2017

September 29, 2017

• Drug Approval Package
  • BONJESTA
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Atenolol Tablets (Updated - Currently in Shortage)
  • Carbidopa and Levodopa Extended Release Tablets (Updated - Currently in Shortage)
  • Dexrazoxane Injection (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • L-Cysteine Hydrochloride Injection (Updated - Currently in Shortage)    
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Sodium Chloride 0.9% Injection Bags (New - Currently in Shortage)    
  • Theophylline Extended Release Tablets and Capsules (Updated - Currently in Shortage)
  • Tolmetin Sodium Tablets, USP (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)