Details for New Drug Application (NDA): 215730
✉ Email this page to a colleague
NDA 215730 describes CARMUSTINE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal, Dr Reddys, Hengrui Pharma, Ingenus Pharms Llc, Meitheal, MSN, Navinta Llc, Norvium Bioscience, and Penn Life, and is included in twelve NDAs. It is available from ten suppliers. Additional details are available on the CARMUSTINE profile page.
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.
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 |
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 | ||||
Complete Access Available with Subscription
