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Generated: July 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203773

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NDA 203773 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 203773
Tradename:DEXMEDETOMIDINE HYDROCHLORIDE
Applicant:Luitpold Pharms Inc
Ingredient:dexmedetomidine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 203773

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date:May 12, 2017TE:APRLD:No

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