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Last Updated: October 14, 2024

Details for New Drug Application (NDA): 209065


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NDA 209065 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, Tagi, Teva Pharms Usa, Wilshire Pharms Inc, Zydus Pharms, and Hq Spclt Pharma, and is included in twenty-nine NDAs. It is available from twenty-five 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-eight suppliers are listed for this compound. Additional details are available on the dexmedetomidine hydrochloride profile page.
Summary for 209065
Pharmacology for NDA: 209065
Mechanism of ActionAdrenergic alpha2-Agonists
Physiological EffectGeneral Anesthesia
Medical Subject Heading (MeSH) Categories for 209065
Suppliers and Packaging for NDA: 209065
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 209065 ANDA Sandoz Inc. 0781-3493 0781-3493-95 10 VIAL in 1 CARTON (0781-3493-95) / 20 mL in 1 VIAL
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride INJECTABLE;INJECTION 209065 ANDA Sandoz Inc. 0781-3494 0781-3494-95 10 BOTTLE in 1 CARTON (0781-3494-95) / 50 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date:Sep 19, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Approval Date:Jun 12, 2020TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date:Jun 12, 2020TE:APRLD:No

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