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Details for New Drug Application (NDA): 202585

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NDA 202585 describes DEXMEDETOMIDINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare Inc, Sun Pharm Inds Inc, Hq Spclt Pharma, Sandoz Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Par Sterile Products, Mylan Institutional, Akorn Inc, and Actavis Inc, and is included in ten NDAs. It is available from ten 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. Twelve suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.

Summary for NDA: 202585

Tradename:
DEXMEDETOMIDINE HYDROCHLORIDE
Applicant:
Akorn Inc
Ingredient:
dexmedetomidine hydrochloride
Patents:0

Pharmacology for NDA: 202585

Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia

Suppliers and Packaging for NDA: 202585

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride
INJECTABLE;INJECTION 202585 ANDA Akorn, Inc. 17478-055 17478-055-02 10 VIAL, SINGLE-DOSE in 1 CARTON (17478-055-02) > 2 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date:Nov 24, 2014TE:APRLD:No


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