ANDA 215730, held by Alembic. Carmustine.
As of Nov 14, 2026, ANDA 215730 (Carmustine), held by Alembic, was first approved by FDA on Oct 20, 2023, with 0 approved supplements and 0 published complete response letters.
Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - Multiple myeloma in combination with prednisone. - Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. - Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carmustine100MG/VIAL · injectable;injection | Carmustine | 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
