June 15, 2018
- Pediatric Exclusivity Statistics (updated)
- Spectrum of Diseases/Conditions (updated)
- Therapeutic Biosimilar Biological Products List (PDF - 134KB)
- Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry (PDF - 132KB)
- FDA Drug Shortages
- Fluorescein Injection (New - Currently in Shortage)
- S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers Guidance for Industry (PDF - 536KB)
- Orange Book
- Orange Book Current Cumulative Supplement 2018 (PDF – 975KB) (updated)
- Additions/Deletions for Prescription and OTC Drug Product Lists (updated)
- Orange Book Data Files (compressed) (ZIP - 704KB) (updated)
- Reference Listed Drugs by ANDA Reference Standard List (PDF - 91KB) (updated)
- Orange Book Patent Listing Dispute List (updated)
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