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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Fish and Richardson
Teva
Deloitte
Johnson and Johnson
US Department of Justice
Healthtrust
Daiichi Sankyo
Cipla

Generated: July 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206628

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NDA 206628 describes DEXMEDETOMIDINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Akorn Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Jiangsu Hengrui Med, Luitpold Pharms Inc, Mylan Institutional, Par Sterile Products, Sandoz Inc, Sun Pharm Inds Inc, Teva Pharms Usa, West-ward Pharms Int, Zydus Pharms Usa Inc, and Hq Spclt Pharma, and is included in fifteen NDAs. It is available from fifteen suppliers. There are two patents protecting this drug. Additional details are available on the DEXMEDETOMIDINE HYDROCHLORIDE profile page.

The generic ingredient in DEXMEDETOMIDINE HYDROCHLORIDE is dexmedetomidine hydrochloride. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 206628
Tradename:DEXMEDETOMIDINE HYDROCHLORIDE
Applicant:Hq Spclt Pharma
Ingredient:dexmedetomidine hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 206628
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 206628
Suppliers and Packaging for NDA: 206628
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;IV (INFUSION) 206628 NDA WG Critical Care, LLC 44567-600 N 44567-600-04
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride SOLUTION;IV (INFUSION) 206628 NDA WG Critical Care, LLC 44567-601 N 44567-601-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)
Approval Date:Oct 21, 2015TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 1MG BASE/10ML (EQ 100MCG BASE/ML)
Approval Date:Oct 21, 2015TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 200MG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date:Jun 22, 2018TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 20, 2036Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Colorcon
Daiichi Sankyo
Healthtrust
Teva
Fish and Richardson
Queensland Health
Cipla
Deloitte

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