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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Chinese Patent Office
AstraZeneca
Cipla
Colorcon
Merck
Fish and Richardson
Fuji
Cantor Fitzgerald

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090838

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NDA 090838 describes LETROZOLE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Apotex Inc, Dr Reddys Labs Ltd, Fresenius Kabi Oncol, Hikma Pharms, Impax Labs, Indicus Pharma, Jiangsu Hengrui Med, Kremers Urban Pharms, Lannett Holdings Inc, Mylan, Natco Pharma Ltd, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, Vintage Pharms Llc, and West-ward Pharms Int, and is included in eighteen NDAs. It is available from fourteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.
Summary for 090838
Tradename:LETROZOLE
Applicant:West-ward Pharms Int
Ingredient:letrozole
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 090838
Mechanism of ActionAromatase Inhibitors
Suppliers and Packaging for NDA: 090838
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LETROZOLE letrozole TABLET;ORAL 090838 ANDA West-Ward Pharmaceuticals Corp. 0054-0269 N 0054-0269-13

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Mallinckrodt
Deloitte
Argus Health
Chinese Patent Office
Cerilliant
McKinsey
Boehringer Ingelheim
US Army

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