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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 215652

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NDA 215652 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 215652

Tradename:	ALBENDAZOLE
Applicant:	Alembic
Ingredient:	albendazole
Patents:	0

Pharmacology for NDA: 215652

Mechanism of Action	Cytochrome P450 1A Inducers

Medical Subject Heading (MeSH) Categories for 215652

Anthelmintics
Anticestodal Agents
Antiprotozoal Agents
Tubulin Modulators

Suppliers and Packaging for NDA: 215652

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBENDAZOLE	albendazole	TABLET;ORAL	215652	ANDA	Alembic Pharmaceuticals Limited	46708-681	46708-681-02	2 TABLET, FILM COATED in 1 BOTTLE (46708-681-02)
ALBENDAZOLE	albendazole	TABLET;ORAL	215652	ANDA	Alembic Pharmaceuticals Limited	46708-681	46708-681-28	28 TABLET, FILM COATED in 1 BOTTLE (46708-681-28)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Sep 4, 2024	TE:	AB	RLD:	No

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