LODINE (etodolac) · Pfizer
LODINE is FDA-approved to treat 3 conditions (same as ETODOLAC).
Details
- Status
- Discontinued
- First Approved
- 1991-01-31
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
LODINE Approval History
What LODINE Treats
3 indicationsLODINE is approved for 3 conditions since its original approval in 1991. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
- Acute Pain
Same approved indications as ETODOLAC (same active ingredient).
Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
FDA Label (PDF)LODINE is FDA-approved to treat 3 conditions — same approved indications as ETODOLAC.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.