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
NDC Product Code52565-040
Application NumberANDA207680
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateAugust 12, 2016
Generic Namefluocinonide
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