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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code11980-211
Application NumberNDA016851
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluorometholone
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 20, 2023
FDA Product Classification
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