October 13, 2017
- Reviews of Pediatric Studies Conducted under BPCA and PREA from 2012 – present (updated)
- Drug Approval Package
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory (updated)
- Orange Book (updated)
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (updated)
- Orange Book Current Cumulative Supplement (updated)
- Orange Book Data Files (compressed) (updated)
- Appendix A: Product Name Index (updated)
- Appendix B: Product Name Sorted by Applicant (updated)
- Appendix C: Uniform Terms (updated)
- Reference Listed Drugs by ANDA Reference Standard List (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
- Orange Book Patent Listing Dispute List (updated)
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) (updated)
- Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for Industry (PDF - 94KB)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
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