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 0.05%Initial U.S. approval: 2008
Approved
Approval ID
8a7254de-a7a2-476d-9295-c41926267ec9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 10, 2020
Manufacturers
FDA
Cipla USA Inc.
DUNS: 078719707
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 Code69097-341
Application NumberANDA211776
Product Classification
M
Marketing Category
C73584
G
Generic Name
DIFLUPREDNATE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateApril 10, 2020
FDA Product Classification
INGREDIENTS (10)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
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
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT