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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 211117

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NDA 211117 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 211117

Tradename:	ALBENDAZOLE
Applicant:	Edenbridge Pharms
Ingredient:	albendazole
Patents:	0

Pharmacology for NDA: 211117

Mechanism of Action	Cytochrome P450 1A Inducers

Medical Subject Heading (MeSH) Categories for 211117

Anthelmintics
Anticestodal Agents
Antiprotozoal Agents
Tubulin Modulators

Suppliers and Packaging for NDA: 211117

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBENDAZOLE	albendazole	TABLET;ORAL	211117	ANDA	Edenbridge Pharmaceuticals LLC.	42799-110	42799-110-02	2 TABLET in 1 BOTTLE (42799-110-02)
ALBENDAZOLE	albendazole	TABLET;ORAL	211117	ANDA	Golden State Medical Supply	51407-258	51407-258-02	2 TABLET in 1 BOTTLE (51407-258-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 14, 2019	TE:	AB	RLD:	No

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