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Details for Generic Name: ketorolac tromethamine

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Summary for Generic Name: ketorolac tromethamine

Drug Master File Entries: see list16
Suppliers: see list7
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents

Pharmacology for Ingredient: ketorolac tromethamine

Clinical Trials for: ketorolac tromethamine

Ketorolac in Postoperative Infants: Pharmacokinetics and Safety
Status: Completed Condition: Postoperative Pain in Infants

Pharmacokinetics of Intranasal Ketorolac in Children
Status: Recruiting Condition: Evaluating Pharmacokinetics of Intranasal Ketorolac; Pain

Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects
Status: Completed Condition: Healthy Subjects

Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients
Status: Completed Condition: Acute Pain

A Pilot Study Comparing the Analgesic Efficacy of IV Ibuprofen and IV Ketorolac
Status: Enrolling by invitation Condition: Chronic Pelvic Pain

Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
Status: Not yet recruiting Condition: Migraine

The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
Status: Completed Condition: Postoperative Pain

Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain
Status: Completed Condition: Interstitial Cystitis

Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers
Status: Completed Condition: Healthy Volunteers

Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy Pain
Status: Enrolling by invitation Condition: Post Vasectomy Pain

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC090017Nov 5, 2009RXNo<disabled><disabled>
Roche Palo
ketorolac tromethamine
INJECTABLE;INJECTION019698Nov 30, 1989DISCNNo<disabled><disabled>
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC022427Jul 22, 2009RXYes8,512,717<disabled>Y<disabled>
ketorolac tromethamine
INJECTABLE;INJECTION075348Nov 28, 2000DISCNNo<disabled><disabled>
Apotex Inc
ketorolac tromethamine
INJECTABLE;INJECTION077201Oct 14, 2005DISCNNo<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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