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McKesson
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Novartis
Fish and Richardson
US Department of Justice
Fuji

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077234

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NDA 077234 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-one 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 077234

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077234

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 077234 ANDA West-Ward Pharmaceuticals Corp 0143-9875 0143-9875-25 25 VIAL in 1 BOX (0143-9875-25) > 3 mL in 1 VIAL (0143-9875-01)
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride INJECTABLE;INJECTION 077234 ANDA West-Ward Pharmaceuticals Corp 0143-9875 0143-9875-10 10 VIAL in 1 BOX (0143-9875-10) > 3 mL in 1 VIAL (0143-9875-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Feb 25, 2008TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Medtronic
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US Army
Colorcon
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Express Scripts
AstraZeneca
Merck
Queensland Health
Baxter

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