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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 208094

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NDA 208094 describes ALBENDAZOLE, which is a drug marketed by Actavis Elizabeth, Alembic, Chartwell Rx, Cipla Ltd, Dr Reddys, Edenbridge Pharms, MSN, Strides Pharma, and Zydus Pharms, and is included in nine NDAs. It is available from sixteen suppliers. Additional details are available on the ALBENDAZOLE profile page.

The generic ingredient in ALBENDAZOLE 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 208094

Tradename:	ALBENDAZOLE
Applicant:	Actavis Elizabeth
Ingredient:	albendazole
Patents:	0

Pharmacology for NDA: 208094

Mechanism of Action	Cytochrome P450 1A Inducers

Medical Subject Heading (MeSH) Categories for 208094

Anthelmintics
Anticestodal Agents
Antiprotozoal Agents
Tubulin Modulators

Suppliers and Packaging for NDA: 208094

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBENDAZOLE	albendazole	TABLET;ORAL	208094	ANDA	Actavis Pharma, Inc.	0591-2712	0591-2712-02	2 TABLET, FILM COATED in 1 BOTTLE (0591-2712-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 20, 2019	TE:	AB	RLD:	No

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