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Last Updated: January 24, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208371

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NDA 208371 describes ABIRATERONE ACETATE, which is a drug marketed by Amneal Pharms, Apotex, Glenmark Pharms, Hikma Pharms, Msn Labs Pvt Ltd, Mylan, Qilu, Rising, Teva Pharms Usa, and Wockhardt Bio Ag, and is included in ten NDAs. It is available from thirteen suppliers. Additional details are available on the ABIRATERONE ACETATE profile page.

The generic ingredient in ABIRATERONE ACETATE is abiraterone acetate. There are twenty-five drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
Summary for 208371
Ingredient:abiraterone acetate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 208371
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208371 ANDA Rising Pharmaceuticals, Inc. 64980-418 64980-418-12 120 TABLET in 1 BOTTLE (64980-418-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Feb 25, 2019TE:ABRLD:No

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