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Last Updated: October 20, 2020

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Details for New Drug Application (NDA): 208446

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NDA 208446 describes ABIRATERONE ACETATE, which is a drug marketed by Amneal Pharms, Apotex, Dr Reddys Labs Ltd, Glenmark Pharms, Hikma, MSN, Mylan, Qilu, Rising, Teva Pharms Usa, and Wockhardt Bio Ag, and is included in eleven NDAs. It is available from fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
Summary for 208446
Ingredient:abiraterone acetate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 208446
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208446 ANDA Mylan Pharmaceuticals Inc. 0378-6920 0378-6920-78 120 TABLET in 1 BOTTLE, PLASTIC (0378-6920-78)
ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 208446 ANDA Mylan Institutional Inc. 42292-057 42292-057-03 30 BLISTER PACK in 1 CARTON (42292-057-03) > 1 TABLET in 1 BLISTER PACK (42292-057-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Oct 31, 2018TE:ABRLD:No

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