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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201072

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NDA 201072 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 201072

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

Pharmacology for NDA: 201072

Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia

Medical Subject Heading (MeSH) Categories for 201072

Suppliers and Packaging for NDA: 201072

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 201072 ANDA Fresenius Kabi USA, LLC 63323-421 63323-421-16 25 VIAL in 1 TRAY (63323-421-16) > 2 mL in 1 VIAL
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 201072 ANDA Fresenius Kabi USA, LLC 63323-421 63323-421-02 25 VIAL in 1 TRAY (63323-421-02) > 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:Sep 18, 2015TE:APRLD:No


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