Fluocinonide
FLUOCINONIDE GEL USP, 0.05%
Approved
Approval ID
943042f4-4e1e-4967-9afd-ad5c19755c3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2020
Manufacturers
FDA
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.
fluocinonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0135
Application NumberANDA072933
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 19, 2019
FDA Product Classification
INGREDIENTS (7)
FLUOCINONIDEActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYL GALLATEInactive
Code: 8D4SNN7V92
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT