loteprednol etabonate Ophthalmic Suspension

Brand(s)
Alrex, Lotemax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bausch & Lomb Incorporated (2014-12-13)
Oldest Current Product
1998-03-09
License(s)
NDA
RxNORM
OPHTHALMIC SUSPENSION\LOTEPREDNOL ETABONATE
FDAOB
OPHTHALMIC\SUSPENSION_DROPS\LOTEPREDNOL ETABONATE
SPL Active
OPHTHALMIC\SUSPENSION/DROPS\LOTEPREDNOL ETABONATE
SPL Moiety
OPHTHALMIC\SUSPENSION/DROPS\LOTEPREDNOL
OPHTHALMIC\SUSPENSION/DROPS\LOTEPREDNOL ETABONATE

product(s) by strength(s)

loteprednol etabonate 2 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080353AlrexNDABausch & Lomb Incorporated1998-03-09LOTEPREDNOL ETABONATEOPHTHALMICSUSPENSION/DROPSNDA02080321c76da0-50a1-41c0-91b8-8cc4dcc27f60

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900007AlrexNDAStat Rx Usa Llc1998-03-09LOTEPREDNOL ETABONATEOPHTHALMICSUSPENSION/DROPS242080353NDA020803cf290d54-26a1-4d22-8cb8-852bdc7b5280
2548684277AlrexNDAPhysicians Total Care, Inc.2002-10-17LOTEPREDNOL ETABONATEOPHTHALMICSUSPENSION/DROPS242080353NDA02080395188fb4-03b6-46ac-a601-41cb82ebde40

loteprednol etabonate 5 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1242080299LotemaxNDABausch & Lomb Incorporated1998-03-09LOTEPREDNOL ETABONATEOPHTHALMICSUSPENSION/DROPSNDA020583f37d74ac-5f9c-40a8-b43b-35148fc66bbe

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684278LotemaxNDAPhysicians Total Care, Inc.2002-10-17LOTEPREDNOL ETABONATEOPHTHALMICSUSPENSION/DROPS242080299NDA020583e7ae762f-5e0b-4f64-9323-8f44db2c0b4c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1NDA020583LOTEMAXBAUSCH AND LOMB INC1998-03-09NDA020583_001
2NDA020803ALREXBAUSCH AND LOMB INC1998-03-09NDA020803_001
3NDA020841LOTEMAXTruePHARMOS CORP1998-03-09NDA020841_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020583_001RXLOTEPREDNOL ETABONATE (0.5%)OPHTHALMICSUSPENSION/DROPSTrue1998-03-09LOTEMAX
2NDA020803_001RXLOTEPREDNOL ETABONATE (0.2%)OPHTHALMICSUSPENSION/DROPSTrue1998-03-09ALREX
3NDA020841_001discontinuedLOTEPREDNOL ETABONATE (0.5%)OPHTHALMICSUSPENSION/DROPSFalse1998-03-09LOTEMAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
121c76da0-50a1-41c0-91b8-8cc4dcc27f60 (view SPL)ALREX loteprednol etabonate ophthalmic suspension, 0.2%prescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2014-12-138242080353
295188fb4-03b6-46ac-a601-41cb82ebde40 (view SPL)ALREX loteprednol etabonate ophthalmic suspension, 0.2%prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-09-101548684277
3cf290d54-26a1-4d22-8cb8-852bdc7b5280 (view SPL)ALREX loteprednol etabonate ophthalmic suspension, 0.2%prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-09-182165900007
4e7ae762f-5e0b-4f64-9323-8f44db2c0b4c (view SPL)LOTEMAX loteprednol etabonate ophthalmic suspension, 0.5%prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-04-051548684278
5f37d74ac-5f9c-40a8-b43b-35148fc66bbe (view SPL)LOTEMAX loteprednol etabonate ophthalmic suspension, 0.5%prescriptionHuman PrescriptionBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2014-03-247242080299

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