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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0862
Application NumberNDA022212
Product Classification
M
Marketing Category
C73594
G
Generic Name
difluprednate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 15, 2020
FDA Product Classification
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