FDA.reportPublic FDA data

LOTEPREDNOL ETABONATE - Food and Drug Administration

Set ID
64ba4d79-5363-eefc-3390-ee5d2a50a350
Type
Indexing - Product Concept
Effective date
2025-03-04
Version
3
Source
DailyMed source

Mapped DailyMed Labels#

Label, Relation, Manufacturer table
LabelRelationManufacturerEffective
Rx only Loteprednol Etabonate Ophthalmic Suspension 0.5% Sterile Ophthalmic SuspensionProduct nameSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)2026-07-13
Rx only Loteprednol Etabonate Ophthalmic Suspension 0.5% Sterile Ophthalmic SuspensionProduct nameNorthStar RxLLC | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)2026-07-09
These highlights do not include all the information needed to use INVELTYS ® safely and effectively. See full prescribing information for INVELTYS. INVELTYS (loteprednol etabonate ophthalmic suspension) 1%, for topical ophthalmic use Initial U.S. Approval: 1998Product nameALCON LABORATORIES, INC.2026-07-01
These highlights do not include all the information needed to use INVELTYS® safely and effectively. See full prescribing information for INVELTYS. INVELTYS (loteprednol etabonate ophthalmic suspension) 1%, for topical ophthalmic use Initial U.S. Approval 1998Product nameAlcon Laboratories, Inc. | Alcon Research LLC | Industriale Chimica SRL2026-07-01
Loteprednol Etabonate Ophthalmic Suspension 0.2%Product namePadagis US LLC2026-05-31
These highlights do not include all the information needed to use INVELTYS® safely and effectively. See full prescribing information for INVELTYS. INVELTYS (loteprednol etabonate ophthalmic suspension) 1%, for topical ophthalmic use Initial U.S. Approval 1998Product nameAlcon Laboratories, Inc. | Alcon Research LLC | Industriale Chimica SRL2026-04-27
Loteprednol Etabonate Ophthalmic Suspension 0.5%Product nameOceanside Pharmaceuticals | Bausch & Lomb Incorporated2026-04-17
Loteprednol Etabonate Ophthalmic Suspension, 0.2%Product nameSentiss Pharmaceuticals LLC | SENTISS AG | Ophtapharm AG2026-04-17
Loteprednol Etabonate Ophthalmic Suspension, 0.5%Product nameSentiss Pharmaceuticals LLC | SENTISS AG | Ophtapharm AG2026-04-17
Rx only Loteprednol Etabonate Ophthalmic Suspension 0.5% Sterile Ophthalmic SuspensionProduct nameSun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)2026-04-15
Rx only Loteprednol Etabonate Ophthalmic Suspension 0.5% Sterile Ophthalmic SuspensionProduct nameNorthStar RxLLC | Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)2026-04-15
These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE OPHTHALMIC GEL safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE OPHTHALMIC GEL. LOTEPREDNOL ETABONATE ophthalmic gel, for topical ophthalmic use Initial U.S. Approval: 1998Product nameSentiss Pharmaceuticals LLC | SENTISS AG | Ophtapharm AG2026-04-15
These highlights do not include all the information needed to use LOTEMAX ® SM safely and effectively. See full prescribing information for LOTEMAX ® SM. LOTEMAX ® SM (loteprednol etabonate ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 1998Product nameBausch & Lomb Incorporated2026-03-31
Loteprednol Etabonate Ophthalmic Suspension, 0.2%Product nameSportpharm LLC2026-03-26
Loteprednol Etabonate Ophthalmic Suspension 0.5% STERILE OPHTHALMIC SUSPENSION Rx OnlyProduct nameLupin Pharmaceuticals, Inc. | LUPIN LIMITED2026-02-12
Loteprednol Etabonate Ophthalmic Suspension, 0.2% STERILE OPHTHALMIC SUSPENSIONProduct nameBausch & Lomb Americas Inc. | Bausch & Lomb Incorporated2026-02-07
These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE AND TOBRAMYCIN OPHTHALMIC SUSPENSION safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE AND TOBRAMYCIN OPHTHALMIC SUSPENSION. LOTEPREDNOL ETABONATE AND TOBRAMYCIN ophthalmic suspension 0.5%/0.3%, for topical ophthalmic use Initial U.S. Approval: 2004Product nameBausch & Lomb Americas Inc. | Bausch & Lomb Incorporated2026-01-20
These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE AND TOBRAMYCIN OPHTHALMIC SUSPENSION safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE AND TOBRAMYCIN OPHTHALMIC SUSPENSION. LOTEPREDNOL ETABONATE AND TOBRAMYCIN ophthalmic suspension 0.5%/0.3%, for topical ophthalmic use Initial U.S. Approval: 2004Product nameBausch & Lomb Americas Inc. | Bausch & Lomb Incorporated2026-01-07
These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE and TOBRAMYCIN OPHTHALMIC SUSPENSION safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE and TOBRAMYCIN OPHTHALMIC SUSPENSION. LOTEPREDNOL ETABONATE and TOBRAMYCIN ophthalmic suspension 0.5%/0.3%, for topical ophthalmic use Initial U.S. Approval: 2004Product nameAlembic Pharmaceuticals Limited | Alembic Pharmaceuticals Limited (F3)2025-12-15
These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE and TOBRAMYCIN OPHTHALMIC SUSPENSION safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE and TOBRAMYCIN OPHTHALMIC SUSPENSION. LOTEPREDNOL ETABONATE and TOBRAMYCIN ophthalmic suspension 0.5%/0.3%, for topical ophthalmic use Initial U.S. Approval: 2004Product nameAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited (F3)2025-12-11
Loteprednol Etabonate Ophthalmic Suspension 0.5% STERILE OPHTHALMIC SUSPENSION Rx OnlyProduct nameLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-10-14
Loteprednol Etabonate Ophthalmic Suspension, 0.5% STERILE OPHTHALMIC SUSPENSIONProduct nameAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals Private Limited2025-05-21
Loteprednol Etabonate Ophthalmic Suspension 0.5% STERILE OPHTHALMIC SUSPENSION Rx onlyProduct nameBausch & Lomb Americas Inc. | Bausch & Lomb Incorporated2025-03-28
These highlights do not include all the information needed to use EYSUVIS™ safely and effectively. See full prescribing information for EYSUVIS. EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, for topical ophthalmic use Initial U.S. Approval: 1998Product nameALCON LABORATORIES, INC.2025-03-11
These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE OPHTHALMIC GEL safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE OPHTHALMIC GEL. LOTEPREDNOL ETABONATE OPHTHALMIC GEL, for topical ophthalmic use Initial U.S. Approval: 1998Product nameBausch & Lomb Americas Inc. | Bausch & Lomb Incorporated2025-02-04
Loteprednol Etabonate Ophthalmic Suspension, 0.2% Sterile Rx onlyProduct nameAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC | Amneal Pharmaceuticals Private Limited2024-12-11
These highlights do not include all the information needed to use LOTEMAX safely and effectively. See full prescribing information for LOTEMAX. LOTEMAX ® (loteprednol etabonate ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 1998Product nameBausch & Lomb Incorporated2024-10-24
Loteprednol Etabonate Ophthalmic Suspension, 0.2%Product nameARMAS PHARMACEUTICALS INC. | SENTISS AG | Ophtapharm AG2024-05-31
Loteprednol Etabonate Ophthalmic Suspension, 0.5%Product namePadagis US LLC2024-04-01
Loteprednol Etabonate Ophthalmic Suspension, 0.5%Product namePadagis US LLC2024-04-01
These highlights do not include all the information needed to use INVELTYS ® safely and effectively. See full prescribing information for INVELTYS. INVELTYS (loteprednol etabonate ophthalmic suspension) 1%, for topical ophthalmic use Initial U.S. Approval: 1998Product nameALCON LABORATORIES, INC.2024-03-27
Loteprednol Etabonate Ophthalmic Suspension 0.2%Product namePadagis US LLC2024-02-29
Loteprednol Etabonate Ophthalmic Suspension 0.2%Product namePadagis US LLC2024-02-29
Loteprednol Etabonate Ophthalmic Suspension, 0.5%Product nameARMAS PHARMACEUTICALS INC. | SENTISS AG | Ophtapharm AG2023-10-26
These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE OPHTHALMIC GEL safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE OPHTHALMIC GEL. LOTEPREDNOL ETABONATE ophthalmic gel, for topical ophthalmic use Initial U.S. Approval: 1998Product nameARMAS PHARMACEUTICALS INC. | SENTISS AG | Ophtapharm AG2023-10-25
Lotemax ® loteprednol etabonate ophthalmic suspension 0.5% STERILE OPHTHALMIC SUSPENSION Rx onlyProduct nameBausch & Lomb Incorporated2023-04-17
These highlights do not include all the information needed to use LOTEMAX ointment safely and effectively. See full prescribing information for LOTEMAX ointment. LOTEMAX ® (loteprednol etabonate ophthalmic ointment) 0.5%, for topical ophthalmic use Initial U.S. Approval: 1998Product nameBausch & Lomb Incorporated2022-11-30
These highlights do not include all the information needed to use ZYLET safely and effectively. See full prescribing information for ZYLET. ZYLET ® (loteprednol etabonate and tobramycin ophthalmic suspension) 0.5%/0.3%, for topical ophthalmic use Initial U.S. Approval: 2004Product nameBausch & Lomb Incorporated | Bausch & Lomb Incoporated2022-04-30
Alrex ® (loteprednol etabonate ophthalmic suspension, 0.2%) STERILE OPHTHALMIC SUSPENSIONProduct nameBausch & Lomb Incorporated2022-03-31
Loteprednol Etabonate Ophthalmic Suspension, 0.5%Product nameAkorn | Akorn Operating Company LLC2022-03-15
These highlights do not include all the information needed to use LOTEPREDNOL ETABONATE OPHTHALMIC GEL safely and effectively. See full prescribing information for LOTEPREDNOL ETABONATE OPHTHALMIC GEL. LOTEPREDNOL ETABONATE OPHTHALMIC GEL 0.5%, for topical ophthalmic use. Initial U.S. Approval: 1998Product nameBausch & Lomb Incorporated2021-03-31
ALREX loteprednol etabonate ophthalmic suspension, 0.2%Product nameSTAT Rx USA LLC | PSS World Medical Inc.2012-09-18
ALREX loteprednol etabonate ophthalmic suspension, 0.2%Product namePhysicians Total Care, Inc.2012-09-10
LOTEMAX® loteprednol etabonate ophthalmic suspension, 0.5%Product namePhysicians Total Care, Inc.2010-04-05