Clobetasol Propionate
Clobetasol Propionate Cream USP, 0.05%
Approved
Approval ID
a84c85fb-05f6-1eb8-444e-c5613766e3e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2018
Manufacturers
FDA
Teligent Pharma, Inc.
DUNS: 011036910
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 Code52565-051
Application NumberANDA209974
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clobetasol Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 27, 2019
FDA Product Classification
INGREDIENTS (15)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
CLOBETASOL PROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 779619577M
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCOL STEARATEInactive
Code: 0324G66D0E
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PEG-8 STEARATEInactive
Code: 2P9L47VI5E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT