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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 200161

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NDA 200161 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 eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.

Summary for 200161

Tradename:	LETROZOLE
Applicant:	Natco Pharma Ltd
Ingredient:	letrozole
Patents:	0

Pharmacology for NDA: 200161

Mechanism of Action	Aromatase Inhibitors

Suppliers and Packaging for NDA: 200161

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LETROZOLE	letrozole	TABLET;ORAL	200161	ANDA	AvPAK	50268-476	50268-476-15	50 BLISTER PACK in 1 BOX (50268-476-15) / 1 TABLET in 1 BLISTER PACK (50268-476-11)
LETROZOLE	letrozole	TABLET;ORAL	200161	ANDA	Breckenridge Pharmaceutical, Inc.	51991-759	51991-759-10	1000 TABLET in 1 BOTTLE (51991-759-10)

Profile for product number 001

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

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