Avodart
These highlights do not include all the information needed to use AVODART safely and effectively. See full prescribing information for AVODART. AVODART (dutasteride) Soft Gelatin CapsulesInitial U.S. Approval: 2001
Approved
Approval ID
813507ec-1fc1-420f-ac5c-5c794b1059cd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5114
Application NumberNDA021319
Product Classification
M
Marketing Category
C73594
G
Generic Name
dutasteride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2011
FDA Product Classification
INGREDIENTS (6)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDESInactive
Code: U72Q2I8C85
Classification: IACT
DUTASTERIDEActive
Quantity: 0.5 mg in 1 1
Code: O0J6XJN02I
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT