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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 211034

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NDA 211034 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 nine 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. Eleven suppliers are listed for this compound. Additional details are available on the albendazole profile page.

Summary for 211034

Tradename:	ALBENDAZOLE
Applicant:	Dr Reddys
Ingredient:	albendazole
Patents:	0

Pharmacology for NDA: 211034

Mechanism of Action	Cytochrome P450 1A Inducers

Medical Subject Heading (MeSH) Categories for 211034

Anthelmintics
Anticestodal Agents
Antiprotozoal Agents
Tubulin Modulators

Suppliers and Packaging for NDA: 211034

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBENDAZOLE	albendazole	TABLET;ORAL	211034	ANDA	Dr.Reddys Laboratories Inc	43598-452	43598-452-02	2 TABLET, FILM COATED in 1 BOTTLE (43598-452-02)
ALBENDAZOLE	albendazole	TABLET;ORAL	211034	ANDA	Dr.Reddys Laboratories Inc	43598-452	43598-452-17	1 BLISTER PACK in 1 CARTON (43598-452-17) / 8 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 26, 2021	TE:	AB	RLD:	No

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