Data updated: May 26, 2026
LODINE (etodolac)
Immunology
Approved 1991-01-31
2
Indications
--
Phase 3 Trials
35
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1991-01-31
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
LODINE Approval History
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
92 FDA actions from 1991 to 2007
May 2005 SUPPL
Label · Labeling
Dec 1997 SUPPL
Mfg
Jun 1996 SUPPL
Mfg
Dec 1994 SUPPL
Label
Jul 1993 SUPPL
Mfg
Mar 1993 SUPPL
Mfg
Jan 1993 SUPPL
Mfg
Oct 1992 SUPPL
Mfg
Feb 1992 SUPPL
Mfg
Nov 1991 SUPPL
Mfg
Oct 1991 SUPPL
Label
Jan 1991 ORIGINAL
New Drug
What LODINE Treats
2 FDA approvalsOriginally approved for its first indication in 1991 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Jan 1991)
- • Approved indication (Jun 1996)
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03127592 FDCETCB-III | ETCAPS0317OR-III | Ph 3 | terminated | Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction |
| NCT01198834 | MRX-7EAT-1005 | Ph 3 | completed | MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains |
| NCT02881619 | UFS | Ph 4 | completed | Etodolac and Post-bleaching Sensitivity |
| NCT01118572 | 177-CL-102 | Ph 3 | completed | A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients |
| NCT01749228 | Ipca/VIN-11/416 | Ph 1 | completed | Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fed Condition |
| NCT01746719 | Ipca/VIN-11/415 | Ph 1 | completed | Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fasting Condition |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LODINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.