Last Updated: September 24, 2026

Details for New Drug Application (NDA): 090491

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NDA 090491 describes LETROZOLE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Apotex Inc, Beijing Yiling, Carnegie, Chartwell Rx, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Pharms, Impax Labs, Indicus Pharma, Lannett Co Inc, Natco Pharma Ltd, Pharmobedient, Strides Pharma Intl, Sun Pharm Inds Ltd, Synthon Pharms, and Teva Pharms, and is included in twenty NDAs. It is available from nineteen suppliers. Additional details are available on the LETROZOLE profile page.

The generic ingredient in LETROZOLE is letrozole. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the letrozole profile page.

Summary for 090491

Tradename:	LETROZOLE
Applicant:	Fresenius Kabi Usa
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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