Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

US Army
Queensland Health
QuintilesIMS
Daiichi Sankyo
Accenture
Baxter
AstraZeneca
Harvard Business School
McKesson
Covington

Generated: October 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206628

« Back to Dashboard
NDA 206628 describes DEXMEDETOMIDINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Sun Pharm Inds Inc, Hq Spclt Pharma, West-ward Pharms Int, Jiangsu Hengrui Med, Sandoz Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Par Sterile Products, Luitpold Pharms Inc, Mylan Institutional, Akorn Inc, and Actavis Inc, and is included in thirteen 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 twelve 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 NDA: 206628

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 206628

Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia

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 44567-600-04 4 VIAL in 1 CARTON (44567-600-04) > 4 mL in 1 VIAL
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride
SOLUTION;IV (INFUSION) 206628 NDA WG Critical Care, LLC 44567-601 44567-601-04 4 VIAL in 1 CARTON (44567-601-04) > 10 mL in 1 VIAL

Summary 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

Summary 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


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Dow
Federal Trade Commission
Julphar
McKesson
Baxter
Merck
Accenture
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot