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Details for Generic Name: dexmedetomidine hydrochloride

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Dexmedetomidine hydrochloride is the generic ingredient in two branded drugs marketed by Mylan Institutional, Par Sterile Products, and Hospira, and is included in three NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for dexmedetomidine hydrochloride. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: dexmedetomidine hydrochloride

Tradenames:2
Patents:6
Applicants:3
NDAs:3
Drug Master File Entries: see list11
Suppliers: see list2

Pharmacology for Ingredient: dexmedetomidine hydrochloride

Tentative approvals for DEXMEDETOMIDINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION100MCG
<disabled><disabled>INJECTABLE; INJECTION100MCG

Clinical Trials for: dexmedetomidine hydrochloride

Dexmedetomidine Sedation With Third Molar Surgery
Status: Terminated Condition: Anesthesia

Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
Status: Completed Condition: Unstable Angina; Coronary Artery Bypass Graft; Dexmedetomidine; Lidocaine; Myocardial Injury; Arrhythmia; Blood Electrolyte Balance

Safety and Efficacy Study of Dexmedetomidine in Pediatrics Ages >= 28 Weeks to <= 44 Weeks Gestational Age
Status: Completed Condition: Sedation

Dexmedetomidine Pharmacokinetics in the Obese
Status: Completed Condition: Obesity

Small Doses of Dexmedetomidine for Emergence Agitation
Status: Recruiting Condition: Emergence Agitation

The Bolus Dose of Dexmedetomidine (ED50) That Avoids Hemodynamic Compromise in Children
Status: Completed Condition: Hemodynamic Instability

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes<disabled><disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes8,242,158*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Dec 17, 1999RXYes<disabled><disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Dec 17, 1999RXYes4,910,214*PED<disabled>Y<disabled>
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes6,716,867*PED<disabled>Y<disabled>
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