Fluocinonide
These highlights do not include all the information needed to use FLUOCINONIDE CREAM safely and effectively. See full prescribing information for FLUOCINONIDE CREAM. Fluocinonide cream, for topical use Initial U.S. Approval: 1971
Approved
Approval ID
43770897-5784-4817-9fb1-7057b5447d5c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2019
Manufacturers
FDA
Teligent Pharma, Inc.
DUNS: 011036910
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 Code52565-079
Application NumberANDA211758
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 12, 2019
FDA Product Classification
INGREDIENTS (9)
fluocinonideActive
Quantity: 1 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
diisopropanolamineInactive
Code: 0W44HYL8T5
Classification: IACT
glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
peg-100 stearateInactive
Code: YD01N1999R
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)Inactive
Code: 4Q93RCW27E
Classification: IACT
Diethylene Glycol Monoethyl EtherInactive
Code: A1A1I8X02B
Classification: IACT