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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 213435

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NDA 213435 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 213435

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

Pharmacology for NDA: 213435

Mechanism of Action	Cytochrome P450 1A Inducers

Medical Subject Heading (MeSH) Categories for 213435

Anthelmintics
Anticestodal Agents
Antiprotozoal Agents
Tubulin Modulators

Suppliers and Packaging for NDA: 213435

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ALBENDAZOLE	albendazole	TABLET;ORAL	213435	ANDA	MSN LABORATORIES PRIVATE LIMITED	69539-151	69539-151-08	2 TABLET in 1 BOTTLE (69539-151-08)
ALBENDAZOLE	albendazole	TABLET;ORAL	213435	ANDA	MSN LABORATORIES PRIVATE LIMITED	69539-151	69539-151-28	28 TABLET in 1 BOTTLE (69539-151-28)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jan 21, 2021	TE:	AB	RLD:	No

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