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Details for Generic Name: hydromorphone hydrochloride

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Summary for Generic Name: hydromorphone hydrochloride

Drug Master File Entries: see list13
Suppliers: see list11
Therapeutic Class:Analgesics

Pharmacology for Ingredient: hydromorphone hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

Clinical Trials for: hydromorphone hydrochloride

Single-arm Study to Assess the Safety of Hydromorphone HCl by Intrathecal Administration
Status: Recruiting Condition: Chronic Pain

Safety and Efficacy Study of Hydromorphone HCl by Intrathecal Administration Using a Programmable Implantable Pump
Status: Recruiting Condition: Management of Chronic Pain

An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
Status: Completed Condition: Postoperative Pain

Association Between Body Size and Response to Hydromorphone in ED
Status: Recruiting Condition: Pain

Methadone and Hydromorphone For Spinal Surgery
Status: Recruiting Condition: Hydromorphone Use; Acute Postoperative Pain; Patient Satisfaction; Chronic Persistent Surgical Pain

Fixed Dose of Intravenous Hydromorphone in the Treatment of Acute Pain
Status: Completed Condition: Acute Pain

Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study
Status: Not yet recruiting Condition: Healthy; Human; Adult; Parturient

Study of Respiratory Depression When Using a Hydromorphone Pain Protocol
Status: Terminated Condition: Pain; Respiratory Depression

An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain
Status: Completed Condition: Pain

An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer
Status: Completed Condition: Cancer; 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
Nesher Pharms
hydromorphone hydrochloride
TABLET;ORAL077311Nov 9, 2005DISCNNo<disabled><disabled>
Purdue Pharm Prods
hydromorphone hydrochloride
TABLET;ORAL019892Dec 7, 1992RXYes6,589,960<disabled>YY<disabled>
Purdue Pharma Lp
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044Sep 24, 2004DISCNNo6,706,281<disabled>Y<disabled>
Watson Labs
hydromorphone hydrochloride
INJECTABLE;INJECTION074317Aug 23, 1995DISCNNo<disabled><disabled>
hydromorphone hydrochloride
TABLET;ORAL074597May 29, 2009RXNo<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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