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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 208327


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NDA 208327 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 208327
Tradename:ABIRATERONE ACETATE
Applicant:Amneal Pharms
Ingredient:abiraterone acetate
Patents:0
Suppliers and Packaging for NDA: 208327
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208327 ANDA AvKARE 42291-024 42291-024-12 120 TABLET in 1 BOTTLE (42291-024-12)
ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208327 ANDA AvKARE 42291-073 42291-073-60 60 TABLET in 1 BOTTLE (42291-073-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Jan 7, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 23, 2020TE:ABRLD:No

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