Fluocinonide
FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05%FLUOCINONIDE GEL USP, 0.05%FLUOCINONIDE OINTMENT USP, 0.05%0262026302640265FOR TOPICAL/EXTERNAL USE ONLYNOT FOR OPHTHALMIC USERx only
Approved
Approval ID
4d42b775-f487-4fb2-83b7-c34baa1cab0b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluocinonide
PRODUCT DETAILS
NDC Product Code52959-652
Application NumberANDA072537
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateSeptember 2, 2011
Generic NameFluocinonide
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT