Fluorometholone Ophthalmic Suspension

Brand(s)
FML, FML Forte Liquifilm, Flarex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Allergan, Inc. (2013-02-18)
Oldest Current Product
1972-02-01
License(s)
NDA, NDA AUTHORIZED GENERIC
RxNORM
OPHTHALMIC SUSPENSION\FLUOROMETHOLONE
FDAOB
OPHTHALMIC\SUSPENSION_DROPS\FLUOROMETHOLONE
OPHTHALMIC\SUSPENSION_DROPS\FLUOROMETHOLONE ACETATE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\FLUOROMETHOLONE
OPHTHALMIC\SUSPENSION/DROPS\FLUOROMETHOLONE
OPHTHALMIC\SUSPENSION\FLUOROMETHOLONE ACETATE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\FLUOROMETHOLONE
OPHTHALMIC\SUSPENSION/DROPS\FLUOROMETHOLONE
OPHTHALMIC\SUSPENSION\FLUOROMETHOLONE

product(s) by strength(s)

fluorometholone acetate 1 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000650096FlarexNDAAlcon Laboratories, Inc.1992-02-06FLUOROMETHOLONE ACETATEOPHTHALMICSUSPENSIONNDA0190796ae122c0-eb4f-4124-96d7-ba5e9a350d35

fluorometholone 1 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1119800211FMLNDAAllergan, Inc.1972-02-01FLUOROMETHOLONEOPHTHALMICSUSPENSION/DROPSNDA016851c374d65a-35b5-4c9e-9069-5148875dc4df

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1607580880NDA AUTHORIZED GENERICPacific Pharma, Inc.1997-10-31FLUOROMETHOLONEOPHTHALMICSOLUTION/DROPSNDA016851af59c420-789d-4c05-b3fc-c3f855bcac24

fluorometholone 2.5 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1119800228FML Forte LiquifilmNDAAllergan, Inc.1986-05-01FLUOROMETHOLONEOPHTHALMICSUSPENSION/DROPSNDA019216b810b4c3-ac7a-4ba5-85bf-ebfaf3b1dabf

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070185FLUOR-OPTrueNOVARTIS PHARMACEUTICALS CORP1986-02-27ANDA070185_001
2NDA016851FMLALLERGAN PHARMACEUTICAL1982-07-28NDA016851_002
3NDA019079FLAREXALCON LABORATORIES INC1986-02-11NDA019079_001
4NDA019216FML FORTEALLERGAN PHARMACEUTICAL1986-04-23NDA019216_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA070185_001discontinuedFLUOROMETHOLONE (0.1%)OPHTHALMICSUSPENSION/DROPSFalse1986-02-27FLUOR-OP
2NDA016851_002RXFLUOROMETHOLONE (0.1%)OPHTHALMICSUSPENSION/DROPSTrue1982-07-28FML
3NDA019079_001RXFLUOROMETHOLONE ACETATE (0.1%)OPHTHALMICSUSPENSION/DROPSTrue1986-02-11FLAREX
4NDA019216_001RXFLUOROMETHOLONE (0.25%)OPHTHALMICSUSPENSION/DROPSFalse1986-04-23FML FORTE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
16ae122c0-eb4f-4124-96d7-ba5e9a350d35 (view SPL)Flarex (fluorometholone acetate ophthalmic suspension) SterileprescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-07-282000650096
2af59c420-789d-4c05-b3fc-c3f855bcac24 (view SPL)FLUOROMETHOLONEophthalmic suspension, USP 0.1%sterileprescriptionHuman PrescriptionPacific Pharma, Inc.MANUFACTURE2013-04-253607580880
3b810b4c3-ac7a-4ba5-85bf-ebfaf3b1dabf (view SPL)FML FORTE (fluorometholone ophthalmic suspension, USP) 0.25%prescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2013-02-184119800228
4c374d65a-35b5-4c9e-9069-5148875dc4df (view SPL)FML (fluorometholone ophthalmic suspension, USP) 0.1%prescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2013-02-135119800211

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII