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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 205869


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NDA 205869 describes LETROZOLE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Apotex Inc, Beijing Yiling, Carnegie, Chartwell Rx, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hikma Pharms, Impax Labs, Indicus Pharma, Lannett Co Inc, Natco Pharma Ltd, Norvium Bioscience, Strides Pharma, Sun Pharm Inds Ltd, Synthon Pharms, and Teva Pharms, and is included in twenty NDAs. It is available from fifteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.
Summary for 205869
Tradename:LETROZOLE
Applicant:Beijing Yiling
Ingredient:letrozole
Patents:0
Pharmacology for NDA: 205869
Mechanism of ActionAromatase Inhibitors
Suppliers and Packaging for NDA: 205869
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LETROZOLE letrozole TABLET;ORAL 205869 ANDA Avet Pharmaceuticals Inc. 23155-875 23155-875-03 30 TABLET, FILM COATED in 1 BOTTLE (23155-875-03)
LETROZOLE letrozole TABLET;ORAL 205869 ANDA Avet Pharmaceuticals Inc. 23155-875 23155-875-09 90 TABLET, FILM COATED in 1 BOTTLE (23155-875-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Nov 14, 2018TE:ABRLD:No

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