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Last Updated: November 2, 2024

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. Eighteen 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 ActionCytochrome 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:DISCNDosage:TABLET;ORALStrength200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 11, 1996TE:RLD:Yes

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