Fluticasone Propionate

Approved

Approval ID

e7ef2aaf-749c-66c9-2bdf-7214ab00060e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 22, 2023

Manufacturers

FDA

Cosette Pharmaceuticals, Inc.

DUNS: 116918230

Products 1

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

NDC Product Code0713-0632

Application NumberANDA077168

Marketing CategoryC73584

Route of AdministrationTOPICAL

Effective DateNovember 22, 2023

Generic NameFluticasone Propionate

MINERAL OILInactive

Code: T5L8T28FGP

Classification: IACT

MICROCRYSTALLINE WAXInactive

Code: XOF597Q3KY

Classification: IACT

SORBITAN SESQUIOLEATEInactive

Code: 0W8RRI5W5A

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FLUTICASONE PROPIONATEActive

Quantity: 0.05 mg in 1 g

Code: O2GMZ0LF5W

Classification: ACTIB