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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209227

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NDA 209227 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 seventeen 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. Nineteen suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
Summary for 209227
Applicant:Glenmark Pharms
Ingredient:abiraterone acetate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 209227
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ABIRATERONE ACETATE abiraterone acetate TABLET;ORAL 209227 ANDA Glenmark Pharmaceuticals Inc., USA 68462-135 68462-135-08 120 TABLET in 1 BOTTLE (68462-135-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Oct 16, 2019TE:ABRLD:No

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