Fluocinonide
Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only
Approved
Approval ID
749d0c98-c048-401c-b59e-2de9dc923af1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2018
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluocinonide
PRODUCT DETAILS
NDC Product Code33261-560
Application NumberANDA073085
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateAugust 23, 2018
Generic NameFluocinonide
INGREDIENTS (6)
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
1,2,6-HEXANETRIOLInactive
Code: W45XXM0XWE
Classification: IACT