Fluocinonide
Fluocinonide Cream, USP 0.05% (Emulsified Base) For External Use Only Not for Ophthalmic Use Rx only
Approved
Approval ID
c229433a-a630-8f9a-8b8c-762ab7e1dd81
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2016
Manufacturers
FDA
Impax Generics
DUNS: 079832487
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluocinonide
PRODUCT DETAILS
NDC Product Code0115-1706
Application NumberANDA074204
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateOctober 25, 2016
Generic NameFluocinonide
INGREDIENTS (9)
FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sorbitan MonostearateInactive
Code: NVZ4I0H58X
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Fluocinonide
PRODUCT DETAILS
NDC Product Code0115-1705
Application NumberANDA074204
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateOctober 25, 2016
Generic NameFluocinonide
INGREDIENTS (9)
FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sorbitan MonostearateInactive
Code: NVZ4I0H58X
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Fluocinonide
PRODUCT DETAILS
NDC Product Code0115-1707
Application NumberANDA074204
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateOctober 25, 2016
Generic NameFluocinonide
INGREDIENTS (9)
FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sorbitan MonostearateInactive
Code: NVZ4I0H58X
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT