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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 210011

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NDA 210011 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 fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the albendazole profile page.

Summary for 210011

Tradename:	ALBENDAZOLE
Applicant:	Strides Pharma
Ingredient:	albendazole
Patents:	0

Pharmacology for NDA: 210011

Mechanism of Action	Cytochrome P450 1A Inducers

Medical Subject Heading (MeSH) Categories for 210011

Anthelmintics
Anticestodal Agents
Antiprotozoal Agents
Tubulin Modulators

Suppliers and Packaging for NDA: 210011

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBENDAZOLE	albendazole	TABLET;ORAL	210011	ANDA	AvKARE	42291-093	42291-093-02	2 TABLET, FILM COATED in 1 BOTTLE (42291-093-02)
ALBENDAZOLE	albendazole	TABLET;ORAL	210011	ANDA	Bryant Ranch Prepack	63629-1221	63629-1221-1	2 TABLET, FILM COATED in 1 BOTTLE (63629-1221-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 7, 2018	TE:		RLD:	No

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