Cutivate
CUTIVATE (fluticasone propionate cream) Cream, 0.05%
Approved
Approval ID
657aee47-558f-4634-a566-fc81dab2fabc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 25, 2013
Manufacturers
FDA
PharmaDerm a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
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 Code10337-332
Application NumberNDA019958
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluticasone propionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 20, 2012
FDA Product Classification
INGREDIENTS (10)
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sodium phosphate, dibasicInactive
Code: GR686LBA74
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
fluticasone propionateActive
Quantity: 0.5 mg in 1 g
Code: O2GMZ0LF5W
Classification: ACTIB
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
cetostearyl alcoholInactive
Code: 2DMT128M1S
Classification: IACT
ceteth-20Inactive
Code: I835H2IHHX
Classification: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
imidureaInactive
Code: M629807ATL
Classification: IACT