Details for New Drug Application (NDA): 214814
NDA 214814 describes CARMUSTINE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal, Dr Reddys, Hengrui Pharma, Ingenus Pharms Llc, Meitheal, MSN, Navinta Llc, Penn Life, and Pharmobedient, 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 is one drug master file entry 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 is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the carmustine profile page.
Summary for 214814
| Tradename: | CARMUSTINE |
| Applicant: | Msn |
| Ingredient: | carmustine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 214814
Suppliers and Packaging for NDA: 214814
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARMUSTINE | carmustine | INJECTABLE;INJECTION | 214814 | ANDA | Novadoz Pharmaceuticals LLC | 72205-198 | 72205-198-01 | 1 KIT in 1 CARTON (72205-198-01) * 3 mL in 1 VIAL (72205-196-01) * 30 mL in 1 VIAL, SINGLE-DOSE (72205-197-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/VIAL | ||||
| Approval Date: | May 11, 2023 | TE: | AP | RLD: | No | ||||
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