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Last Updated: September 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077431

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NDA 077431 describes EXEMESTANE, which is a drug marketed by Alvogen, Amneal Pharms, Breckenridge, Cipla, Hikma, Mayne Pharma Inc, Mylan, Qilu, Upsher Smith Labs, and Zydus Pharms, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the EXEMESTANE profile page.

The generic ingredient in EXEMESTANE is exemestane. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the exemestane profile page.
Summary for 077431
Formulation / Manufacturing:see details
Pharmacology for NDA: 077431
Mechanism of ActionAromatase Inhibitors
Suppliers and Packaging for NDA: 077431
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXEMESTANE exemestane TABLET;ORAL 077431 ANDA West-Ward Pharmaceuticals Corp 0054-0080 0054-0080-13 30 TABLET, FILM COATED in 1 BOTTLE (0054-0080-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Apr 1, 2011TE:ABRLD:No

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