Abiraterone Acetate
Abiraterone Acetate Tablets, USP Rx Only 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
7f82d549-6654-1efd-e053-2991aa0aa28d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Abiraterone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-024
Application NumberANDA208327
Product Classification
M
Marketing Category
C73584
G
Generic Name
Abiraterone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
ABIRATERONE ACETATEActive
Quantity: 250 mg in 1 1
Code: EM5OCB9YJ6
Classification: ACTIB