loteprednol etabonate Ophthalmic Ointment

Brand(s)
Lotemax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2011-04-01)
Oldest Current Product
2011-04-15
License(s)
NDA
RxNORM
OPHTHALMIC OINTMENT\LOTEPREDNOL ETABONATE
FDAOB
OPHTHALMIC\OINTMENT\LOTEPREDNOL ETABONATE
SPL Active
OPHTHALMIC\OINTMENT\LOTEPREDNOL ETABONATE
SPL Moiety
OPHTHALMIC\OINTMENT\LOTEPREDNOL

product(s) by strength(s)

loteprednol etabonate 0.005 mg/mg ophthalmic ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080443LotemaxNDABausch & Lomb Incorporated2011-04-15LOTEPREDNOL ETABONATEOPHTHALMICOINTMENTNDA200738902a3c6b-2625-44ec-a077-926e012b3176

application(s)

#idtitleapplicantapprovedexclusivityapproved drug
1NDA200738LOTEMAXBAUSCH AND LOMB INC2011-04-15PEDIATRIC EXCLUSIVITY [2014-10-15]NDA200738_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200738_001RXLOTEPREDNOL ETABONATE (0.5%)OPHTHALMICOINTMENTTrue2011-04-15LOTEMAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1902a3c6b-2625-44ec-a077-926e012b3176 (view SPL)These highlights do not include all the information needed to use Lotemax ointment safely and effectively. See full prescribing information for Lotemax (loteprednol etabonate ophthalmic ointment) 0.5%. Initial U.S. Approval: 1998prescriptionHuman PrescriptionBausch & Lomb IncorporatedMANUFACTURE2011-04-0111242080443

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