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Fluocinonide

Fluocinonide Topical Solution USP, 0.05%

Approved
Approval ID

dfa1ebda-d746-4c28-b91a-b78dacfaed91

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 1, 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 Code71085-006
Application NumberANDA074799
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateMarch 1, 2017
Generic NameFluocinonide

INGREDIENTS (6)

FluocinonideActive
Quantity: 0.5 mg in 1 mL
Code: 2W4A77YPAN
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
diisopropyl adipateInactive
Code: P7E6YFV72X
Classification: IACT

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Fluocinonide - FDA Drug Approval Details