Clobetasol Propionate
Clobetasol Propionate Cream, USP, 0.05%Clobetasol Propionate Ointment, USP, 0.05%
Approved
Approval ID
39f719f6-4e44-4aff-bad1-7529bf75bda2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 2, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-3584
Application NumberANDA074220
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateApril 2, 2012
Generic NameClobetasol Propionate
INGREDIENTS (15)
CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 779619577M
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCOL STEARATEInactive
Code: 0324G66D0E
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYOXYL 8 STEARATEInactive
Code: 2P9L47VI5E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT