loteprednol etabonate Ophthalmic Gel

Brand(s)
Lotemax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2014-10-28)
Oldest Current Product
2012-10-12
License(s)
NDA
RxNORM
OPHTHALMIC GEL\LOTEPREDNOL ETABONATE
FDAOB
OPHTHALMIC\GEL\LOTEPREDNOL ETABONATE
SPL Active
OPHTHALMIC\GEL\LOTEPREDNOL ETABONATE
SPL Moiety
OPHTHALMIC\GEL\LOTEPREDNOL

product(s) by strength(s)

loteprednol etabonate 0.005 mg/mg ophthalmic gel

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080503LotemaxNDABausch & Lomb Incorporated2012-10-12LOTEPREDNOL ETABONATEOPHTHALMICGELNDA2028729a666065-d467-42b8-8ecd-0ec1de9986d5

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202872LOTEMAXBAUSCH AND LOMB INC2012-09-28p5800807, SUBSTANCENEW DOSAGE FORM [2015-09-28]NDA202872_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202872_001RXLOTEPREDNOL ETABONATE (0.5%)OPHTHALMICGELTrue2012-09-28LOTEMAX

patent(s)

#idexpiration dateapplication(s)
1p5800807 (view patent)2017-01-29NDA202872

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19a666065-d467-42b8-8ecd-0ec1de9986d5 (view SPL)These highlights do not include all the information needed to use LOTEMAX (loteprednol etabonate ophthalmic gel) 0.5% safely and effectively. See full prescribing information for LOTEMAX. LOTEMAX (loteprednol etabonate ophthalmic gel) 0.5% Initial U.S. Approval: 1998prescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2014-10-285242080503

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