June 4, 2026
- Public Notifications:
- Final Guidance: Certain Postapproval Requirements and Resources for ANDAs
June 3, 2026
- CDER Statement: FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury
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.
