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Details for New Drug Application (NDA): 206628

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NDA 206628 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: 206628

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
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
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

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