carmustine

FDA Drug Profile — carmustine, Carmustine, Gliadel

carmustine is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including carmustine, Carmustine, Gliadel. Available dosage forms: kit, wafer.

Drug Details

Generic Name
carmustine
Brand Names
carmustine, Carmustine, Gliadel
Application Number
ANDA211229
Sponsor
Amneal Pharmaceuticals LLC
NDC Codes
7
Dosage Forms
KIT, WAFER
Routes
INTRAVENOUS, INTRACAVITARY
Active Ingredients
CARMUSTINE

Indications and Usage

1 INDICATIONS AND USAGE 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 ( 1 ) Multiple myeloma-in combination with prednisone ( 1 ) Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1 ) Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs ( 1 ) 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.