Details for New Drug Application (NDA): 215730
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The generic ingredient in CARMUSTINE is carmustine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the carmustine profile page.
Summary for 215730
Tradename: | CARMUSTINE |
Applicant: | Alembic |
Ingredient: | carmustine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 215730
Suppliers and Packaging for NDA: 215730
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARMUSTINE | carmustine | INJECTABLE;INJECTION | 215730 | ANDA | Alembic Pharmaceuticals Limited | 46708-659 | 46708-659-02 | 1 KIT in 1 CARTON (46708-659-02) * 30 mL in 1 VIAL, SINGLE-DOSE (46708-658-31) * 3 mL in 1 VIAL (46708-660-03) |
CARMUSTINE | carmustine | INJECTABLE;INJECTION | 215730 | ANDA | Alembic Pharmaceuticals Inc. | 62332-659 | 62332-659-02 | 1 KIT in 1 CARTON (62332-659-02) * 30 mL in 1 VIAL, SINGLE-DOSE (62332-658-31) * 3 mL in 1 VIAL (62332-660-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/VIAL | ||||
Approval Date: | Oct 20, 2023 | TE: | AP | RLD: | No |
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