ANDA 215368, held by Pharmobedient. Carmustine.
As of Nov 13, 2026, ANDA 215368 (Carmustine), held by Pharmobedient, was first approved by FDA on Mar 3, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 3, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carmustine100MG/VIAL ยท injectable;injection | Carmustine | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
