Details for New Drug Application (NDA): 213446

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NDA 213446 describes AMIODARONE HYDROCHLORIDE, which is a drug marketed by Acella, Bedford, Bedford Labs, Ben Venue, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Zhejiang Poly Pharm, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Sa, Pharmobedient, Rubicon Research, Taro, Teva, Teva Pharms, Unichem, Upsher Smith Labs, and Zydus Pharms Usa Inc, and is included in thirty-one NDAs. It is available from thirty-four suppliers. Additional details are available on the AMIODARONE HYDROCHLORIDE profile page.

The generic ingredient in AMIODARONE HYDROCHLORIDE is amiodarone hydrochloride. There are fifteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 3A Inhibitors

Anti-Arrhythmia Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Potassium Channel Blockers
Sodium Channel Blockers
Vasodilator Agents

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	213446	ANDA	Unichem Pharmaceuticals (USA), Inc.	29300-359	29300-359-05	500 TABLET in 1 BOTTLE (29300-359-05)
AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	213446	ANDA	Unichem Pharmaceuticals (USA), Inc.	29300-359	29300-359-16	60 TABLET in 1 BOTTLE (29300-359-16)

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Jul 21, 2020	TE:	AB	RLD:	No

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