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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201804

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NDA 201804 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, Lannett Co 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 seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.
Summary for 201804
Tradename:LETROZOLE
Applicant:Indicus Pharma
Ingredient:letrozole
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 201804
Mechanism of ActionAromatase Inhibitors
Suppliers and Packaging for NDA: 201804
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LETROZOLE letrozole TABLET;ORAL 201804 ANDA INDICUS PHARMA LLC 24724-030 N 24724-030-01
LETROZOLE letrozole TABLET;ORAL 201804 ANDA INDICUS PHARMA LLC 24724-030 N 24724-030-03

Profile for product number 001

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

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