ANDA 216015, held by Lupin. Midostaurin.
As of Nov 14, 2026, ANDA 216015 (Midostaurin), held by Lupin, was first approved by FDA on May 10, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 10, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Midostaurin25MG ยท capsule;oral | Midostaurin | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
