February 15, 2019
- GDUFA Implementation Quarterly Meetings between FDA and Industry (updated)
- Competitive Generic Therapies; Draft Guidance for Industry (PDF - 186KB)
- Orange Book (updated)
- Orange Book Current Cumulative Supplement 2019 (PDF – 408KB) (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
- Orange Book Data Files (compressed) (ZIP - 801KB) (updated)
- Reference Listed Drugs by ANDA Reference Standard List (PDF - 92KB) (updated)
- Orange Book Patent Listing Dispute List (updated)
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