Clobetasol Propionate
These highlights do not include all the information needed to use CLOBETASOL PROPIONATE LOTION safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE LOTION.CLOBETASOL PROPIONATE lotion, for topical useInitial U.S. Approval: 1985
Approved
Approval ID
31c443c8-3cb8-4250-93f3-4ae2b4659f0b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2022
Manufacturers
FDA
Akorn
DUNS: 117696873
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 Code50383-978
Application NumberANDA211348
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMarch 9, 2022
Generic NameClobetasol Propionate
INGREDIENTS (8)
CLOBETASOL PROPIONATEActive
Quantity: .05 g in 100 mL
Code: 779619577M
Classification: ACTIB
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 71DD5V995L
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PEG-6 ISOSTEARATEInactive
Code: 0E2639OTJY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT