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Generic Name: dexmedetomidine hydrochloride

Summary for Generic Name: dexmedetomidine hydrochloride

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: see list11
Suppliers: see list1

Pharmacology for Ingredient: dexmedetomidine hydrochloride

Tentative approvals for DEXMEDETOMIDINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION100MCG
<disabled><disabled>INJECTABLE; INJECTION100MCG
<disabled><disabled>INJECTABLE; INJECTION100MCG (base) /mL

Clinical Trials for: dexmedetomidine hydrochloride

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

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

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

Dexmedetomidine in Spinal Anesthesia
Status: Recruiting Condition: Blood Pressure; Anxiety

Caudal Versus Intravenous Dexmedetomidine for Supplementation of Caudal Analgesia in Children
Status: Completed Condition: Inguinal Hernia; Cryptorchidism

Bioavailability of Dexmedetomidine After Intranasal Administration
Status: Completed Condition: Sedation

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. Patented / Exclusive Use
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes<disabled>PEDIATRIC EXCLUSIVITY
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes<disabled>REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes8,648,106*PED<disabled>Y
Hospira
PRECEDEX
dexmedetomidine hydrochloride
INJECTABLE;INJECTION021038Mar 13, 2013RXYes8,338,470*PED<disabled>Y
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