ANDA 209278, held by Penn Life. Carmustine.
As of Nov 14, 2026, ANDA 209278 (Carmustine), held by Penn Life, was first approved by FDA on Apr 2, 2019, with 0 approved supplements and 0 published complete response letters.
Carmustine for Injection is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents 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 |
|---|---|---|---|
| Apr 2, 2019 | 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
