Details for New Drug Application (NDA): 020666
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NDA 020666 describes ALBENZA, which is a drug marketed by Impax Labs Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the ALBENZA profile page.
The generic ingredient in ALBENZA is albendazole. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the albendazole profile page.
The generic ingredient in ALBENZA is albendazole. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the albendazole profile page.
Summary for 020666
| Tradename: | ALBENZA |
| Applicant: | Impax Labs Inc |
| Ingredient: | albendazole |
| Patents: | 0 |
Pharmacology for NDA: 020666
| Mechanism of Action | Cytochrome P450 1A Inducers |
Medical Subject Heading (MeSH) Categories for 020666
Suppliers and Packaging for NDA: 020666
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALBENZA | albendazole | TABLET;ORAL | 020666 | NDA | Amneal Pharmaceuticals of New York LLC | 0115-1701 | 0115-1701-49 | 2 TABLET, FILM COATED in 1 BOTTLE (0115-1701-49) |
| ALBENZA | albendazole | TABLET;ORAL | 020666 | NDA | Amneal Pharmaceuticals LLC | 64896-693 | 64896-693-49 | 2 TABLET, FILM COATED in 1 BOTTLE (64896-693-49) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 11, 1996 | TE: | RLD: | Yes | |||||
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