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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60219-1585
Application NumberANDA216348
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluorometholone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 11, 2024
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60219-1586
Application NumberANDA216348
Product Classification
M
Marketing Category
C73584
G
Generic Name
fluorometholone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJanuary 11, 2024
FDA Product Classification
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