Data updated: Nov 8, 2026
KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE (ketorolac tromethamine) · Lupin
Pain
Approved 2019-07-01
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
1
Indication
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-07-01
- Routes
- IRRIGATION
- Dosage Forms
- SOLUTION
KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2019 to 2019
What KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE Treats
1 FDA approvalsOriginally approved for its first indication in 2019 .
- Other (1)
Other
(1 approval)- • Approved indication (Jul 2019)Letter
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Clinical Trial Registry
35 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05324358 | NTM-001-CT001 | Ph 3 | suspended | Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy |
| NCT06513208 | HP-00109853 | Ph 4 | recruiting | Ketorolac Effects on Post-operative Pain and Lumbar Fusion |
| NCT05641363 KETODOSE | KETODOSE20221107 | Ph 3 | completed | Comparison of Ketorolac at Three Doses in Children With Acute Pain |
| NCT03913702 results posted | UTMB IRB #: 18-0156 | Ph 2 | terminated | Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement |
| NCT03453541 | 4923 | Ph 4 | terminated | Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy |
| NCT04733326 | CairoU0 | Ph 1 | completed | Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial. |
| NCT06395428 | WMed-2024-1032 | Ph 4 | recruiting | Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department |
| NCT06160778 KETOAPP | 23-0952 | Ph 3 | recruiting | Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain |
| NCT04666701 | EMS1319 - ESCÓCIA | Ph 2 | withdrawn | Efficacy and Safety of Escócia Association in the Treatment of Acute Pain |
| NCT05382546 | NTM-001-AHC001 | Ph 1 | completed | A Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects |
| NCT04439396 | 19-387 | Ph 1 | completed | Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid Use |
| NCT04554862 | M419 | Ph 4 | completed | The Analgesic Efficacy of Magnesium and Ketorolac in Ultrasound Supraclavicular Block |
| NCT04939987 | IRB00074034 | Ph 2, Ph 3 | withdrawn | Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy |
| NCT01471899 | CTRGEMS0611 | Ph 3 | completed | Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment |
| NCT01471886 | CTREMS0611 | Ph 3 | completed | Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment |
| NCT02902770 results posted | 2016-03-09 | Ph 4 | completed | Intravenous Lidocaine and Ketorolac for Pain Management |
| NCT02923687 | AZadUMS-P/190/D | Ph 2 | completed | Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain |
| NCT03410212 IANB | IR.IAU.DENTAL.REC.1396,31 | Ph 2 | completed | Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain |
| NCT02658149 results posted | 2015-422 | Ph 4 | completed | Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty |
| NCT02313675 results posted | PRO14110464 | Ph 4 | completed | Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries |
| NCT03007381 KANGAROO | KANGAROO | Ph 4 | withdrawn | Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn |
| NCT02638831 | DRL_RUS/PMS/2012/KETG | Ph 4 | completed | Ketorol Gel in Gonarthrosis and Low Back Pain |
| NCT02729285 | 2014MEKY042 | Ph 4 | completed | Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery |
| NCT02601911 | AzadUMS P/66/D | Ph 2 | completed | Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection |
| NCT02614118 | AZadUMS-P/139/D | Ph 2 | completed | Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain |
| NCT02536430 | AZadUMS-P/212/D | Ph 2 | completed | Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block |
| NCT00907114 | HJM 1667/09.03.24 | Ph 2 | completed | Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy |
| NCT01596166 EDMigraine-4 | EDMIGR-004-01 | Ph 4 | completed | Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department |
| NCT01542190 | 0018014600011 | Ph 4 | completed | Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery |
| NCT02000401 | 0703-2012-SPRIX | Ph 4 | completed | Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain |
| NCT01365624 results posted | ROX 2007-02 | Ph 1 | completed | Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects |
| NCT01436032 | N1539-05 | Ph 3 | terminated | Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery |
| NCT01291472 | 3214 2011-000367-27 | Ph 4 | completed | Disposition of Intravenous Ketorolac |
| NCT01015235 | KAI-1678-002 | Ph 2 | completed | Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain |
| NCT01021761 results posted | 2009 0199 | Ph 4 | completed | A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification |
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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.
KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE FDA Label Details
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.