CDER New October 17, 2016

What's New on the FDA Drugs Site

October 14, 2016

• ANDA Submissions – Prior Approval Supplements Under GDUFA Guidance for Industry (PDF - 177KB)
• Drug Firm Annual Registration Status Download File (updated)
• Frequently Asked Questions on Potassium Iodide (KI) (updated)
• Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee) Charter (updated)
• Drug Firm Annual Registration Status (updated)
• National Drug Code Directory
• Orange Book (updated)
  • Appendix A: Product Name Index (PDF - 148KB)
  • Appendix B: Product Name Sorted by Applicant (PDF - 532KB)
  • Appendix C: Uniform Terms (PDF - 59KB)
  • Orange Book Current Cumulative Supplement (PDF - 1.3MB)
  • Orange Book Data Files (compressed) (ZIP - 658KB)
  • Orange Book FR Safety or Effectiveness Determinations List (PDF) (PDF - 485KB)
  • September 2016: Additions and Deletions to the Drug Product List (PDF - 124KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)