Abiraterone acetate
These highlights do not include all the information needed to use ABIRATERONE ACETATE TABLETS safely and effectively. See full prescribing information for ABIRATERONE ACETATE TABLETS. ABIRATERONE ACETATE tablets, for oral use Initial U.S. Approval: 2011
Approved
Approval ID
76f9bb2f-4946-4391-9e7d-e4f867cf84db
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Wockhardt USA LLC.
DUNS: 170508365
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Abiraterone acetate
PRODUCT DETAILS
NDC Product Code64679-021
Application NumberANDA208380
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 29, 2023
Generic NameAbiraterone acetate
INGREDIENTS (8)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ABIRATERONE ACETATEActive
Quantity: 250 mg in 1 1
Code: EM5OCB9YJ6
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT