Fluocinonide
Fluocinonide Ointment USP, 0.05% For External Use Only. Not For Ophthalmic Use. Rx only
Approved
Approval ID
222eaeb1-778b-4bd6-801a-13d51eadf111
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2018
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 Code52565-040
Application NumberANDA207680
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluocinonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2016
FDA Product Classification
INGREDIENTS (6)
Propylene CarbonateInactive
Code: 8D08K3S51E
Classification: IACT
FluocinonideActive
Quantity: 0.5 mg in 1 g
Code: 2W4A77YPAN
Classification: ACTIB
Glyceryl MonostearateInactive
Code: 230OU9XXE4
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
White WaxInactive
Code: 7G1J5DA97F
Classification: IACT