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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 210726


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NDA 210726 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 210726
Tradename:ABIRATERONE ACETATE
Applicant:Teva Pharms Usa
Ingredient:abiraterone acetate
Patents:0
Suppliers and Packaging for NDA: 210726
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 210726 ANDA Actavis Pharma, Inc. 0591-4365 0591-4365-60 60 TABLET, FILM COATED in 1 BOTTLE (0591-4365-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jan 26, 2023TE:ABRLD:No

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