Clobetasol Propionate
CLOBETASOL PROPIONATE OINTMENT USP, 0.05%
Approved
Approval ID
a862de41-1500-9136-e053-2a95a90a6080
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 3, 2023
Manufacturers
FDA
AvKARE
DUNS: 796560394
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clobetasol propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-077
Application NumberANDA209701
Product Classification
M
Marketing Category
C73584
G
Generic Name
clobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 3, 2023
FDA Product Classification
INGREDIENTS (4)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITAN SESQUIOLEATEInactive
Code: 0W8RRI5W5A
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 779619577M
Classification: ACTIB