Details for New Drug Application (NDA): 017422
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NDA 017422 describes BICNU, which is a drug marketed by Avet Lifesciences and is included in one NDA. It is available from one supplier. Additional details are available on the BICNU profile page.
The generic ingredient in BICNU 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 BICNU 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 017422
| Tradename: | BICNU |
| Applicant: | Avet Lifesciences |
| Ingredient: | carmustine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017422
Suppliers and Packaging for NDA: 017422
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BICNU | carmustine | INJECTABLE;INJECTION | 017422 | NDA AUTHORIZED GENERIC | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-649 | 23155-649-41 | 1 KIT in 1 CARTON (23155-649-41) * 3 mL in 1 VIAL (23155-648-31) * 30 mL in 1 VIAL, SINGLE-DOSE (23155-647-31) |
| BICNU | carmustine | INJECTABLE;INJECTION | 017422 | NDA AUTHORIZED GENERIC | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-790 | 23155-790-41 | 1 KIT in 1 CARTON (23155-790-41) * 3 mL in 1 VIAL (23155-789-31) * 30 mL in 1 VIAL, SINGLE-DOSE (23155-788-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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