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Fluocinonide

FluocinonideCream USP, 0.05%

Approved
Approval ID

f96f4f15-9b99-446e-8e58-6a99ade5ba77

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 15, 2017

Manufacturers
FDA

IPG PHARMACEUTICALS, INC.

DUNS: 080441238

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 Code71085-005
Application NumberANDA071500
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateFebruary 15, 2017
Generic NameFluocinonide

INGREDIENTS (8)

FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
polyethylene glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
1,2,6-hexanetriolInactive
Code: W45XXM0XWE
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT

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Fluocinonide - FDA Drug Approval Details