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Last Updated: July 13, 2024

Details for New Drug Application (NDA): 204023

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NDA 204023 describes DEXMEDETOMIDINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Am Regent, Amneal, Amneal Pharms Co, Baxter Hlthcare Corp, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hengrui Pharma, Hikma, Meitheal, Milla Pharms, Mylan Institutional, Mylan Labs Ltd, Piramal Critical, Rising, Sandoz, Slayback Pharma Llc, Tagi, Teva Pharms Usa, Zydus Pharms, and Hq Spclt Pharma, and is included in twenty-nine NDAs. It is available from twenty-six suppliers. There are two patents protecting this drug. Additional details are available on the DEXMEDETOMIDINE HYDROCHLORIDE profile page.

The generic ingredient in DEXMEDETOMIDINE HYDROCHLORIDE is dexmedetomidine hydrochloride. There are fourteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 204023
Applicant:Accord Hlthcare
Ingredient:dexmedetomidine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 204023
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 204023
Suppliers and Packaging for NDA: 204023
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 204023 ANDA Accord Healthcare Inc. 16729-239 16729-239-93 25 VIAL in 1 CARTON (16729-239-93) / 2 mL in 1 VIAL (16729-239-30)
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 204023 ANDA Accord Healthcare Inc. 16729-432 16729-432-93 25 VIAL in 1 CARTON (16729-432-93) / 2 mL in 1 VIAL (16729-432-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date:Feb 9, 2016TE:APRLD:No

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