CDER New April 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  

April 17, 2020

• Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications
• International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets USP, 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A
• Manual of Policy and Procedures (MAPP) 5200.7 Rev.1 ANDA Amendments and Supplements Reviewed by the Division of Filing Review
• Orange Book
  • Orange Book Current Cumulative Supplement (updated)
  • Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
  • Orange Book Data Files (compressed) (updated)
  • Reference Listed Drugs by ANDA Reference Standard List (updated)
  • Orange Book Patent Listing Dispute List (updated)
  • Appendix A: Product Name Index (updated)
  • Appendix B: Product Name Sorted by Applicant (updated)
  • Appendix C: Uniform Terms (updated)