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Fluocinonide Gel

Fluocinonide Gel

Approved
Approval ID

3bd220d7-9a5a-3341-6bd5-619387267200

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 18, 2023

Manufacturers
FDA

Alvogen Inc.

DUNS: 008057330

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fluocinonide Gel

PRODUCT DETAILS

NDC Product Code47781-533
Application NumberNDA017373
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateApril 30, 2015
Generic NameFluocinonide Gel

INGREDIENTS (7)

FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Propyl GallateInactive
Code: 8D4SNN7V92
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
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Fluocinonide Gel - FDA Approval | MedPath