FML
sterile
Approved
Approval ID
c374d65a-35b5-4c9e-9069-5148875dc4df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2023
Manufacturers
FDA
Allergan, Inc.
DUNS: 144796497
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluorometholone
PRODUCT DETAILS
NDC Product Code11980-211
Application NumberNDA016851
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateDecember 20, 2023
Generic Namefluorometholone
INGREDIENTS (10)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
FLUOROMETHOLONEActive
Quantity: 1 mg in 1 mL
Code: SV0CSG527L
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT