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Serving leading biopharmaceutical companies globally:

Moodys
Citi
Argus Health
Colorcon
Fuji
US Department of Justice
Harvard Business School
Cerilliant
Queensland Health
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205867

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NDA 205867 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, West-ward Pharms Int, and Hq Spclt Pharma, 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 205867

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

Pharmacology for NDA: 205867

Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia

Medical Subject Heading (MeSH) Categories for 205867

Suppliers and Packaging for NDA: 205867

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 205867 ANDA AuroMedics Pharma LLC 55150-209 55150-209-02 25 VIAL in 1 CARTON (55150-209-02) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date:Mar 17, 2016TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Medtronic
Federal Trade Commission
Fuji
Julphar
Harvard Business School
Cipla
Baxter
Cerilliant
Dow

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.

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