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Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200161

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NDA 200161 describes LETROZOLE, which is a drug marketed by Apotex Inc, Indicus Pharma, Jiangsu Hengrui Med, Accord Hlthcare, Impax Labs, West-ward Pharms Int, Lannett Holdings Inc, Natco Pharma Ltd, Sun Pharm Inds Ltd, Teva Pharms, Vintage Pharms Llc, Mylan, Dr Reddys Labs Ltd, Fresenius Kabi Oncol, Actavis Totowa, Hikma Pharms, Synthon Pharms, and Kremers Urban Pharms, and is included in eighteen 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 NDA: 200161

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 200161

Mechanism of ActionAromatase 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 Breckenridge Pharmaceutical, Inc. 51991-759 51991-759-10 1000 TABLET in 1 BOTTLE (51991-759-10)
LETROZOLE
letrozole
TABLET;ORAL 200161 ANDA Breckenridge Pharmaceutical, Inc. 51991-759 51991-759-33 30 TABLET in 1 BOTTLE (51991-759-33)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jun 3, 2011TE:ABRLD:No


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