Clobetasol Propionate
These highlights do not include all the information needed to use CLOBETASOL PROPIONATE FOAM safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE FOAM. CLOBETASOL PROPIONATE foam, for topical useInitial U.S. Approval: 1985
Approved
Approval ID
db8c7a36-e950-44b9-b2ff-7fede2e87407
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 12, 2023
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
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
NDC Product Code68462-608
Application NumberANDA210809
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateJune 21, 2022
Generic Nameclobetasol propionate
INGREDIENTS (9)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 779619577M
Classification: ACTIB
POTASSIUM CITRATEInactive
Code: EE90ONI6FF
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT