DUREZOL
These highlights do not include all the information needed to use DUREZOL safely and effectively. See full prescribing information for DUREZOL. DUREZOL (difluprednate ophthalmic emulsion)Initial U.S. Approval: 2008
Approved
Approval ID
830dd64e-8b1a-4bc4-86bd-e0a0915b59e7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 27, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
difluprednate
PRODUCT DETAILS
NDC Product Code0078-0862
Application NumberNDA022212
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateNovember 15, 2020
Generic Namedifluprednate
INGREDIENTS (10)
DIFLUPREDNATEActive
Quantity: 0.5 mg in 1 mL
Code: S8A06QG2QE
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT