Data updated: May 26, 2026
ULTRAM (tramadol hydrochloride)
Pain
Approved 1995-03-03
3
Indications
--
Phase 3 Trials
31
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1995-03-03
- Routes
- ORAL
- Dosage Forms
- TABLET
ULTRAM Approval History
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
72 FDA actions from 1995 to 2023 · 1 indication expansions
Feb 2001 SUPPL
Mfg
Jun 2000 SUPPL
Mfg
Apr 2000 SUPPL
Mfg
Mar 2000 SUPPL
Mfg
Mar 2000 SUPPL
Mfg
Aug 1999 SUPPL
Mfg
Nov 1997 SUPPL
Label
Nov 1996 SUPPL
Mfg
Oct 1996 SUPPL
Mfg
Mar 1996 SUPPL
Label
Dec 1995 SUPPL
Mfg
Oct 1995 SUPPL
Mfg
Mar 1995 ORIGINAL
New Drug
What ULTRAM Treats
3 FDA approvalsOriginally approved for its first indication in 1995 . Covers 3 distinct patient populations.
- Other (3)
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Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07440069 TRAMPA | PO-UNAH-49-7-2026 | Ph 4 | recruiting | Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor |
| NCT04991493 | QPOST | Ph 4 | recruiting | Effect of Tramadol on Postoperative Sore Throat After General Anesthesia |
| NCT05125978 CANADÁ | EMS1120 - CANADÁ | Ph 2 | withdrawn | Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain |
| NCT05390905 | HSK21542-303 | Ph 3 | completed | A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment |
| NCT04613830 | 515 | Ph 3 | completed | Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients |
| NCT03775629 | CG100650-1-01 | Ph 1 | completed | Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers |
| NCT03477851 TramIsch | WNOZA/1/2017 | Ph 4 | completed | Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis |
| NCT04178109 | 17200 | Ph 2 | completed | Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach. |
| NCT00737048 results posted | CR015109 JNS013-JPN-03 | Ph 3 | completed | A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain |
| NCT01307020 DEX-TRA 02 results posted | DEX-TRA 02 2010-022798-32 | Ph 2 | completed | Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain |
| NCT00766675 results posted | CR015319 TRAMMAPPAI4033 | Ph 4 | completed | An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain |
| NCT00983736 | BVF-324-302 | Ph 3 | terminated | Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation |
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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.
ULTRAM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.