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, for oral use Initial U.S. Approval: 2001
Approved
Approval ID
35f16489-00d7-0f8b-3cd6-2abbe277af19
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 30, 2016
Manufacturers
FDA
Intergel Pharmaceuticals Inc
DUNS: 964464114
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 Code62112-8068
Application NumberANDA206373
Product Classification
M
Marketing Category
C73584
G
Generic Name
dutasteride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 30, 2016
FDA Product Classification
INGREDIENTS (7)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESInactive
Code: U72Q2I8C85
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DUTASTERIDEActive
Quantity: 0.5 mg in 1 1
Code: O0J6XJN02I
Classification: ACTIB