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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 091638

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NDA 091638 describes LETROZOLE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Apotex Inc, Beijing Yiling, Chartwell Rx, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Pharms, Impax Labs, Indicus Pharma, Lannett Co Inc, Natco Pharma Ltd, Norvium Bioscience, Ryan Labs, Strides Pharma, Sun Pharm Inds Ltd, Synthon Pharms, and Teva Pharms, and is included in twenty NDAs. It is available from fifteen suppliers. Additional details are available on the LETROZOLE profile page.

The generic ingredient in LETROZOLE is letrozole. There are twenty-four drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.

Summary for 091638

Tradename:	LETROZOLE
Applicant:	Impax Labs
Ingredient:	letrozole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Jun 3, 2011	TE:		RLD:	No

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