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Fluocinonide

Fluocinonide Ointment, 0.05%

Approved
Approval ID

bccf8840-3919-9f2d-0c91-496f224f76a5

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code47781-569
Application NumberNDA016909
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 2, 2017
FDA Product Classification

INGREDIENTS (6)

FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
White WaxInactive
Code: 7G1J5DA97F
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Propylene CarbonateInactive
Code: 8D08K3S51E
Classification: IACT

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Fluocinonide - FDA Drug Approval Details