Fluorometholone Ophthalmic Ointment

Brand(s)
FML
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Allergan, Inc. (2013-02-14)
Oldest Current Product
1985-12-09
License(s)
NDA
RxNORM
OPHTHALMIC OINTMENT\FLUOROMETHOLONE
FDAOB
OPHTHALMIC\OINTMENT\FLUOROMETHOLONE
SPL Active
OPHTHALMIC\OINTMENT\FLUOROMETHOLONE
SPL Moiety
OPHTHALMIC\OINTMENT\FLUOROMETHOLONE

product(s) by strength(s)

fluorometholone 0.001 mg/mg ophthalmic ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000230316FMLNDAAllergan, Inc.1985-12-09FLUOROMETHOLONEOPHTHALMICOINTMENTNDA0177603102d420-8842-4809-9aa1-7be91ac7d0ab

application(s)

#idtitleapplicantapprovedapproved drug
1NDA017760FMLALLERGAN PHARMACEUTICAL1985-09-04NDA017760_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA017760_001RXFLUOROMETHOLONE (0.1%)OPHTHALMICOINTMENTTrue1985-09-04FML

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13102d420-8842-4809-9aa1-7be91ac7d0ab (view SPL)FML (fluorometholone ophthalmic ointment) 0.1%prescriptionHuman PrescriptionAllergan, Inc.MANUFACTURE2013-02-143000230316

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