fluorometholone ophthalmic suspension
sterile
Approved
Approval ID
e7988a3b-e432-4d42-a8d2-63ca017e6a01
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluorometholone
PRODUCT DETAILS
NDC Product Code60219-1585
Application NumberANDA216348
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateJanuary 11, 2024
Generic Namefluorometholone
INGREDIENTS (10)
FLUOROMETHOLONEActive
Quantity: 1 mg in 1 mL
Code: SV0CSG527L
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
fluorometholone
PRODUCT DETAILS
NDC Product Code60219-1586
Application NumberANDA216348
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateJanuary 11, 2024
Generic Namefluorometholone
INGREDIENTS (10)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
FLUOROMETHOLONEActive
Quantity: 1 mg in 1 mL
Code: SV0CSG527L
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT