CDER New August 20, 2018

August 17, 2018

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA alerts drug makers of a recall of porcine thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China
• National Drug Code Directory (updated)
• Orange Book updates
  • July 2018: Additions and Deletions to the Drug Product List (PDF - 170 KB)
  • Orange Book Data Files (compressed)  (ZIP - 708KB) 
  • Orange Book Patent Listing Dispute List (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (PDF - 91KB) 
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)