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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078190

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NDA 078190 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 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 078190

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

Pharmacology for NDA: 078190

Mechanism of ActionAromatase Inhibitors

Suppliers and Packaging for NDA: 078190

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LETROZOLE letrozole TABLET;ORAL 078190 ANDA Mylan Pharmaceuticals Inc. 0378-2071 0378-2071-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2071-05)
LETROZOLE letrozole TABLET;ORAL 078190 ANDA Physicians Total Care, Inc. 54868-6252 54868-6252-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-6252-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 24, 2008TE:ABRLD:No


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