Clobetasol Propionate
Clobetasol Propionate Ointment USP, 0.05%
Approved
Approval ID
1145ee2c-e7b4-1bd2-77fb-74245bbdef94
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2019
Manufacturers
FDA
Teligent Pharma, Inc.
DUNS: 011036910
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 Code52565-039
Application NumberANDA208589
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobetasol Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2019
FDA Product Classification
INGREDIENTS (4)
Clobetasol PropionateActive
Quantity: 0.5 mg in 1 g
Code: 779619577M
Classification: ACTIB
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
Sorbitan SesquioleateInactive
Code: 0W8RRI5W5A
Classification: IACT