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Details for New Drug Application (NDA): 091638

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NDA 091638 describes LETROZOLE, which is a drug marketed by Apotex Inc, Indicus Pharma, Jiangsu Hengrui Med, Accord Hlthcare, Impax Labs, Roxane, 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 nineteen 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. Twenty suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the letrozole profile page.

Summary for NDA: 091638

Tradename:
LETROZOLE
Applicant:
Impax Labs
Ingredient:
letrozole
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Summary for product number 001

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


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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