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Generated: April 30, 2017

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Details for New Drug Application (NDA): 078578

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NDA 078578 describes AMIODARONE HYDROCHLORIDE, which is a drug marketed by Hospira, Wockhardt, Sandoz, Mylan Institutional, Bedford, Taro Pharm, Zydus Pharms Usa Inc, Akorn, Hikma Farmaceutica, Teva Pharms, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Teva Pharms Usa, Murty Pharms, Apotex Inc, Hospira Inc, Ben Venue, Mylan, Mayne Pharma Inc, Intl Medication Sys, Par Sterile Products, Teva, and Bedford Labs, and is included in twenty-eight NDAs. It is available from thirty-three 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-six suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

Summary for NDA: 078578

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078578

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amiodarone hydrochloride
TABLET;ORAL 078578 ANDA APOTEX Corp 60505-2658 60505-2658-0 10 BLISTER PACK in 1 CARTON (60505-2658-0) > 10 TABLET in 1 BLISTER PACK
amiodarone hydrochloride
TABLET;ORAL 078578 ANDA APOTEX Corp 60505-2658 60505-2658-3 60 TABLET in 1 BOTTLE (60505-2658-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Nov 6, 2008TE:ABRLD:No

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