Clobetasol Propionate
Clobetasol Propionate Topical Solution USP, 0.05%
Approved
Approval ID
f5ea346b-f507-4224-88a6-4c891c4b1ad5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2019
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 Code51672-1293
Application NumberANDA075224
Product Classification
M
Marketing Category
C73584
G
Generic Name
clobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 5, 2019
FDA Product Classification
INGREDIENTS (5)
clobetasol propionateActive
Quantity: 0.5 mg in 1 mL
Code: 779619577M
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
Carbomer Homopolymer Type B (Allyl Sucrose Crosslinked)Inactive
Code: Z135WT9208
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT