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Daiichi Sankyo
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Dow
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Covington
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Accenture
Argus Health
Chinese Patent Office

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203972

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NDA 203972 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, and Hq Spclt Pharma, and is included in fourteen NDAs. It is available from twelve suppliers. 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. Thirteen suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 203972
Tradename:DEXMEDETOMIDINE HYDROCHLORIDE
Applicant:Par Sterile Products
Ingredient:dexmedetomidine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203972
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 203972
Suppliers and Packaging for NDA: 203972
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 203972 ANDA Par Pharmaceutical, Inc. 42023-146 N 42023-146-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date:Aug 18, 2014TE:APRLD:No

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Medtronic
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