Dutasteride
These highlights do not include all the information needed to use DUTASTERIDE CAPSULES safely and effectively. See full prescribing information for DUTASTERIDE CAPSULES. DUTASTERIDE CAPSULES, oral Initial U.S. Approval: 2001
Approved
Approval ID
a63dc429-cbcd-44ba-a87a-96ab623ab0e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 2015
Manufacturers
FDA
Impax Generics
DUNS: 079832487
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dutasteride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0115-1438
Application NumberANDA200899
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dutasteride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2015
FDA Product Classification
INGREDIENTS (12)
DUTASTERIDEActive
Quantity: 0.5 mg in 1 1
Code: O0J6XJN02I
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESInactive
Code: U72Q2I8C85
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT