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Accenture
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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077069

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NDA 077069 describes AMIODARONE HYDROCHLORIDE, which is a drug marketed by Akorn, Aurobindo Pharma Ltd, Bedford, Bedford Labs, Ben Venue, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Hospira Inc, Intl Medication Sys, Mylan Institutional, Par Sterile Products, Teva Pharms Usa, Wockhardt, Apotex Inc, Mayne Pharma Inc, Murty Pharms, Mylan, Sandoz, Taro Pharm, Teva, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-nine 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-seven suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 077069
Tradename:AMIODARONE HYDROCHLORIDE
Applicant:Murty Pharms
Ingredient:amiodarone hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077069
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 077069 ANDA Cameron Pharmaceuticals, LLC 42494-307 N 42494-307-03
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride TABLET;ORAL 077069 ANDA Cameron Pharmaceuticals, LLC 42494-308 N 42494-308-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Apr 8, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Apr 8, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Oct 4, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
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QuintilesIMS
Boehringer Ingelheim
Johnson and Johnson
Fish and Richardson
Fuji
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