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
NDC Product Code0115-1438
Application NumberANDA200899
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 3, 2015
Generic NameDutasteride
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