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Serving 500+ biopharmaceutical companies globally:

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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090934

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NDA 090934 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 twenty 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-one suppliers are listed for this compound. Additional details are available on the letrozole profile page.

Summary for NDA: 090934

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

Pharmacology for NDA: 090934

Mechanism of ActionAromatase Inhibitors

Suppliers and Packaging for NDA: 090934

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LETROZOLE
letrozole
TABLET;ORAL 090934 ANDA KAISER FOUNDATION HOSPITALS 0179-0169 0179-0169-70 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0179-0169-70)
LETROZOLE
letrozole
TABLET;ORAL 090934 ANDA Accord Healthcare, Inc. 16729-034 16729-034-01 100 TABLET, FILM COATED in 1 BOTTLE (16729-034-01)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
US Department of Justice
Merck
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Chubb

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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