August 14, 2026
- September 9 Public Meeting: Addressing the Public Health Effects of Opioid Medications
- Orange Book
- Approved Drug Products with Therapeutic Equivalence Evaluations
- 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)
August 13, 2026
- FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma
- Draft Guidance: Container Closure Systems for Human Drugs and Biological Products
- September 16, 2026 Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA)
This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.
