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Details for New Drug Application (NDA): 078984

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NDA 078984 describes ANASTROZOLE, which is a drug marketed by Sandoz, Natco Pharma Ltd, Zydus Pharms Usa Inc, Synthon Pharms, Kremers Urban Pharms, Dr Reddys Labs Ltd, Impax Labs Inc, Santos Biotech, Mylan, Apotex Inc, Teva Pharms, Cipla Ltd, Accord Hlthcare, Sun Pharm Inds Ltd, Watson Labs, Roxane, and Fresenius Kabi Oncol, and is included in seventeen NDAs. It is available from thirty-three suppliers. Additional details are available on the ANASTROZOLE profile page.

The generic ingredient in ANASTROZOLE is anastrozole. There are twenty-four drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the anastrozole profile page.

Summary for NDA: 078984

Watson Labs
Therapeutic Class:Antineoplastics

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Jun 28, 2010TE:RLD:No

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