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Active ingredient

Loteprednol Etabonate

27 finished FDA listings contain Loteprednol Etabonate as their only active ingredient; 4 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
LOTEPREDNOL ETABONATE
Dosage forms
Gel, Ointment, Suspension, Suspension/ Drops
Routes
Ophthalmic, Topical
Manufacturers / labelers
12
Strengths listed
10 mg/ml · 2 mg/ml · 2.5 mg/ml · 3.8 mg/g · 5 mg/g · 5 mg/ml
Brand names in FDA listings
Alrex, Eysuvis, Inveltys, Lotemax, Lotemax Sm

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 52177

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020583BAUSCH AND LOMB1998-03-092
NDA 020803BAUSCH AND LOMB1998-03-092
NDA 200738BAUSCH AND LOMB2011-04-151
NDA 202872BAUSCH AND LOMB INC2012-09-283
NDA 210565ALCON LABS INC2018-08-222
NDA 208219BAUSCH AND LOMB INC2019-02-221
ANDA 207609SENTISS2019-04-172
NDA 210933ALCON LABS INC2020-10-261
ANDA 212080SENTISS2021-02-102
ANDA 212450SUN PHARM2021-02-262
ANDA 215933SENTISS2023-04-123
ANDA 215719LUPIN2024-04-241
ANDA 215203PADAGIS US2024-07-101
ANDA 216345AMNEAL2024-12-132
ANDA 215204PADAGIS US2025-01-291
ANDA 217484AMNEAL2025-05-201

Official labeling on DailyMed

Showing the 12 most recent of 26 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.