CDER New August 20, 2020

Updated Monday through Friday

• Drug Firm Annual Registration Status
• Drug Firm Annual Registration Status Download File 
• National Drug Code Directory
• NDC Unfinished Drugs Excluded Database File 
• NDC Database Excluded Packages and Products 
• Wholesale Distributor and Third-Party Logistics Providers Reporting  

August 19, 2020

• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Famotidine Injection (New - Currently in Shortage)
  • Famotidine Injection (Updated - Currently in Shortage)
  • Levetiracetam Immediate-Release Oral Tablets, USP (Updated - Currently in Shortage)
  • Sodium Bicarbonate Injection, USP (Updated - Currently in Shortage)
• Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry
• Manual of Policies and Procedures (MAPP) 5241.2 Rev. 1 Consolidation of ANDAs by the Office of Generic Drugs
• SCA Pharmaceuticals (SCA) Is Issuing a Voluntary Nationwide Recall of Heparin Sodium Compounded Products Due to Incorrect Preservative (Benzyl Alcohol)