ANDA 211011, held by Ingenus Pharms LLC. Carmustine.
As of Nov 13, 2026, ANDA 211011 (Carmustine), held by Ingenus Pharms LLC, was first approved by FDA on Jun 21, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2022 | 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