clobetasol propionate
Clobetasol Propionate Topical Solution USP, 0.05%(Scalp Application)Rx Only FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
Approved
Approval ID
afa1c879-36b9-401e-85d4-638ceec8f444
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 28, 2016
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
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 Code40032-028
Application NumberANDA206075
Product Classification
M
Marketing Category
C73584
G
Generic Name
clobetasol propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 28, 2016
FDA Product Classification
INGREDIENTS (5)
CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 mL
Code: 779619577M
Classification: ACTIB
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT