Last Updated: November 8, 2026

Details for New Drug Application (NDA): 220438

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NDA 220438 describes LETROZOLE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Apotex Inc, 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, Teva Pharms, and Zydus Lifesciences, and is included in twenty-one 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 220438

Tradename:	LETROZOLE
Applicant:	Zydus Lifesciences
Ingredient:	letrozole
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Sep 14, 2026	TE:	AB	RLD:	No

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