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
4cad5edd-1f9b-4537-8506-24d93fe935ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Woodward Pharma Services LLC
DUNS: 080406260
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 Code69784-712
Application NumberNDA021319
Product Classification
M
Marketing Category
C73594
G
Generic Name
dutasteride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (6)
DUTASTERIDEActive
Quantity: 0.5 mg in 1 1
Code: O0J6XJN02I
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERYL CAPRYLOCAPRATEInactive
Code: U72Q2I8C85
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT