Clobetasol Propionate
Clobetasol Propionate Topical Solution, USP, 0.05%
Approved
Approval ID
86126839-2dee-45fd-9bf0-29578538743a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 23, 2018
Manufacturers
FDA
HyGen Pharmaceuticals, Inc.
DUNS: 849181706
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 Code70030-166
Application NumberANDA074222
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMarch 23, 2018
Generic NameClobetasol Propionate
INGREDIENTS (5)
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CLOBETASOL PROPIONATEActive
Quantity: 0.4625 mg in 1 mL
Code: 779619577M
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: K61870Z308
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT