CDER New April 17, 2017

What's New on the FDA Drugs Site

April 14, 2017

• Drug Approval Packages
  
  • ArmonAir RespiClick
  • AirDuo RespiClick
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA announces Standard Homeopathic Company’s nationwide voluntary recall of Hyland’s teething tablets
• FDA Drug Shortages
  • Potassium Phosphate Injection (Currently in Shortage)
• National Drug Code Directory
• Orange Book (updated)
  • March 2017: Additions and Deletions to the Drug Product List (PDF - 731KB)
  • Orange Book Current Cumulative Supplement (PDF - 874MB)
  • Orange Book Data Files (compressed) (ZIP - 647KB)
  • Appendix A: Product Name Index (PDF-167KB)
  • Appendix B: Product Name Sorted by Applicant (PDF-394KB)
  • Appendix C: Uniform Terms (PDF-24KB)
  • Reference Listed Drugs by ANDA Reference Standard List (PDF - 86KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
• First Generic Drug Approvals (updated)