Difluprednate
These highlights do not include all the information needed to use DIFLUPREDNATE OPHTHALMIC EMULSION safely and effectively. See full prescribing information for DIFLUPREDNATE OPHTHALMIC EMULSION. DIFLUPREDNATE ophthalmic emulsion, for topical ophthalmic use Initial U.S. Approval: 2008
Approved
Approval ID
3612ff2a-c4bf-4322-b5bc-e7b867575321
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 29, 2019
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Difluprednate ophthalmic
PRODUCT DETAILS
NDC Product Code69238-1380
Application NumberANDA211526
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateDecember 29, 2023
Generic NameDifluprednate ophthalmic
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
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT