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Generated: November 21, 2018

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Details for New Drug Application (NDA): 020666

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NDA 020666 describes ALBENZA, which is a drug marketed by Amedra Pharms Llc and Impax Labs Inc and is included in two NDAs. It is available from six 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. Seven 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
Formulation / Manufacturing:see details
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 Amedra Pharmaceuticals LLC 52054-550 52054-550-22 2 TABLET, FILM COATED in 1 BOTTLE (52054-550-22)
ALBENZA albendazole TABLET;ORAL 020666 NDA Lineage Therapeutics Inc 54505-055 54505-055-22 2 TABLET, FILM COATED in 1 BOTTLE (54505-055-22)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jun 11, 1996TE:ABRLD:Yes

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