Details for New Drug Application (NDA): 210179
✉ Email this page to a colleague
NDA 210179 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 210179
| Tradename: | CARMUSTINE |
| Applicant: | Navinta Llc |
| Ingredient: | carmustine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 210179
Suppliers and Packaging for NDA: 210179
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARMUSTINE | carmustine | INJECTABLE;INJECTION | 210179 | ANDA | Navinta LLC | 68475-503 | 68475-503-01 | 1 KIT in 1 CARTON (68475-503-01) * 3 mL in 1 VIAL (68475-502-01) * 30 mL in 1 VIAL, SINGLE-DOSE (68475-500-01) |
| CARMUSTINE | carmustine | INJECTABLE;INJECTION | 210179 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1525 | 70710-1525-9 | 1 KIT in 1 CARTON (70710-1525-9) * 3 mL in 1 VIAL (70710-1523-1) * 30 mL in 1 VIAL, SINGLE-DOSE (70710-1524-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/VIAL | ||||
| Approval Date: | Sep 11, 2018 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
