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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 079029


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NDA 079029 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, Norvium Bioscience, Rubicon, 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 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-three suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 079029
Suppliers and Packaging for NDA: 079029
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 079029 ANDA McKesson Corporation dba SKY Packaging 63739-051 63739-051-10 10 BLISTER PACK in 1 BOX (63739-051-10) / 10 TABLET in 1 BLISTER PACK
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 079029 ANDA Zydus Lifesciences Limited 65841-631 65841-631-05 500 TABLET in 1 BOTTLE (65841-631-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 16, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jan 6, 2023TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jan 6, 2023TE:ABRLD:No

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