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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Citi
Farmers Insurance
Moodys
Federal Trade Commission
QuintilesIMS
Harvard Business School
Teva

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075761

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NDA 075761 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-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-eight suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 075761
Tradename:AMIODARONE HYDROCHLORIDE
Applicant:Fresenius Kabi Usa
Ingredient:amiodarone hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075761
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 075761 ANDA General Injectables and Vaccines, Inc. 52584-616 N 52584-616-03
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 075761 ANDA APP Pharmaceuticals, LLC 63323-616 N 63323-616-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Oct 15, 2002TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
McKinsey
Chubb
UBS
McKesson
Daiichi Sankyo
Cerilliant
QuintilesIMS

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