CLOBETASOL PROPIONATE
Clobetasol Propionate Topical Solution USP, 0.05%
Approved
Approval ID
a75cac17-c0d1-403a-8a63-80b2d43e3169
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 12, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-486
Application NumberANDA212881
Product Classification
M
Marketing Category
C73584
G
Generic Name
CLOBETASOL PROPIONATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 12, 2023
FDA Product Classification
INGREDIENTS (5)
CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 mL
Code: 779619577M
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT