Details for New Drug Application (NDA): 209278
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NDA 209278 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 209278
| Tradename: | CARMUSTINE |
| Applicant: | Penn Life |
| Ingredient: | carmustine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 209278
Suppliers and Packaging for NDA: 209278
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARMUSTINE | carmustine | INJECTABLE;INJECTION | 209278 | ANDA | KVK-Tech, Inc. | 10702-361 | 10702-361-99 | 1 KIT in 1 CARTON (10702-361-99) * 30 mL in 1 VIAL, SINGLE-DOSE (10702-366-03) * 3 mL in 1 VIAL (10702-365-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/VIAL | ||||
| Approval Date: | Apr 2, 2019 | TE: | AP | RLD: | No | ||||
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