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.
Fluticasone Propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0632
Application NumberANDA077168
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluticasone Propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateNovember 22, 2023
FDA Product Classification
INGREDIENTS (5)
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