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Last Updated: November 2, 2024

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, Dr Reddys, Florida, Glenmark Speclt, Hikma, MSN, Mylan, Novugen, Qilu, Rising, Teva Pharms Usa, and Wockhardt Bio Ag, and is included in fifteen NDAs. It is available from twenty-four 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. Twenty-six suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
Summary for 208371
Tradename:ABIRATERONE ACETATE
Applicant:Rising
Ingredient:abiraterone acetate
Patents:0
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 Pharma Holdings, 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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