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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202126

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NDA 202126 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. 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 202126
Tradename:DEXMEDETOMIDINE HYDROCHLORIDE
Applicant:Sun Pharm Inds Inc
Ingredient:dexmedetomidine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202126
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 202126
Suppliers and Packaging for NDA: 202126
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 202126 ANDA Sun Pharmaceuticals Industries, Inc. 57664-596 N 57664-596-40
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 202126 ANDA Medical Purchasing Solutions, LLC 71872-7122 N 71872-7122-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date:Aug 20, 2015TE:APRLD:No

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