Fluocinonide
Fluocinonide Topical Solution USP, 0.05%
Approved
Approval ID
dfa1ebda-d746-4c28-b91a-b78dacfaed91
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2017
Manufacturers
FDA
IPG PHARMACEUTICALS, INC.
DUNS: 080441238
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 Code71085-006
Application NumberANDA074799
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 1, 2017
FDA Product Classification
INGREDIENTS (6)
FluocinonideActive
Quantity: 0.5 mg in 1 mL
Code: 2W4A77YPAN
Classification: ACTIB
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
diisopropyl adipateInactive
Code: P7E6YFV72X
Classification: IACT