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 use Initial U.S. Approval: 1985
Approved
Approval ID
d8f560c8-e223-46f0-8afb-b418f2b6399c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 28, 2020
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
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 Code51672-4193
Application NumberANDA208779
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobetasol Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 18, 2020
FDA Product Classification
INGREDIENTS (9)
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
Clobetasol PropionateActive
Quantity: 0.5 mg in 1 g
Code: 779619577M
Classification: ACTIB
cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
potassium citrateInactive
Code: EE90ONI6FF
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT