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Serving leading biopharmaceutical companies globally:

Harvard Business School
US Department of Justice
Daiichi Sankyo
Express Scripts
Farmers Insurance

Generated: October 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077161

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NDA 077161 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-two 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-five suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.

Summary for NDA: 077161

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077161

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amiodarone hydrochloride
INJECTABLE;INJECTION 077161 ANDA Sagent Pharmaceuticals 25021-302 25021-302-66 10 SYRINGE in 1 CARTON (25021-302-66) > 3 mL in 1 SYRINGE
amiodarone hydrochloride
INJECTABLE;INJECTION 077161 ANDA Gland Pharma Limited 68083-112 68083-112-01 10 SYRINGE in 1 CARTON (68083-112-01) > 3 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Apr 20, 2005TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Fish and Richardson
US Army
Federal Trade Commission

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