July 13, 2018
- FDA approves TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox
- Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry (PDF - 57KB)
- ICH Harmonised Guideline: Q3D(R1) Elemental Impurities (PDF - 177KB)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- National Drug Code Directory (updated)
- 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)
- Appendix A: Product Name Index (PDF - 168KB) (updated)
- Appendix B: Product Name Sorted by Applicant (PDF - 410KB) (updated)
- Appendix C: Uniform Terms (PDF - 25KB) (updated)
- Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)
.png)
No hay comentarios:
Publicar un comentario