CDER New July 17, 2017

What's New on the FDA Drugs Site

July 14, 2107

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Dexrazoxane Injection (New - Currently in Shortage)
  • Dexrazoxane 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)
  • Methotrexate Sodium Injection (Updated - Currently in Shortage)
  • Methylprednisolone Sodium Succinate for Injection, USP (Updated - Currently in Shortage)
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
  • Potassium Phosphate Injection (Updated - Currently in Shortage)
  • Rocuronium Bromide Injection (Updated - Currently in Shortage)
  • Sodium Acetate Injection, USP (Updated - Currently in Shortage)
  • Sodium Chloride 23.4% Injection (Updated - Currently in Shortage)
• Most Recent Changes to the Inactive Ingredient Directory
• National Drug Code Directory
• Orange Book (updated)
  • June 2017: Additions and Deletions to the Drug Product List (PDF - 202KB)
  • Appendix A: Product Name Index (PDF - 167KB)
  • Appendix B: Product Name Sorted by Applicant (PDF - 394KB)
  • Appendix C: Uniform Terms (PDF - 24KB)
  • Orange Book Current Cumulative Supplement (PDF - 2.4MB) 
  • Orange Book Data Files (compressed) (ZIP - 638KB)
  • Orange Book Patent Listing Dispute List
  • Reference Listed Drugs by ANDA Reference Standard List (PDF - 86KB)
• Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse & Abuse (PDF - 352 KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• First Generic Drug Approvals (updated)