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Generated: May 30, 2017

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Amiodarone hydrochloride - Generic Drug Details

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What are the generic sources for amiodarone hydrochloride and what is the scope of amiodarone hydrochloride freedom to operate?

Amiodarone hydrochloride
is the generic ingredient in four branded drugs marketed by Hospira, Wockhardt, Sandoz, Mylan Institutional, Bedford, Taro Pharm, Baxter Hlthcare, Zydus Pharms Usa Inc, Akorn, Hikma Farmaceutica, Upsher Smith, Teva Pharms, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Teva Pharms Usa, Murty Pharms, Wyeth Pharms Inc, Apotex Inc, Hospira Inc, Ben Venue, Mylan, Mayne Pharma Inc, Intl Medication Sys, Par Sterile Products, Teva, and Bedford Labs, and is included in thirty-two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amiodarone hydrochloride has thirty-eight patent family members in nineteen countries.

There are fifteen drug master file entries for amiodarone hydrochloride. Thirty-six suppliers are listed for this compound.

Summary for Generic Name: amiodarone hydrochloride

Drug Master File Entries: see list15
Suppliers / Packagers: see list36
Bulk Api Vendors: see list49
Clinical Trials: see list1,020
Patent Applications: see list794
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amiodarone hydrochloride at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upsher Smith
amiodarone hydrochloride
TABLET;ORAL075135-002Apr 12, 2005ABRXNoNo► Subscribe► Subscribe
Taro Pharm
amiodarone hydrochloride
TABLET;ORAL075424-001Mar 30, 2001ABRXNoNo► Subscribe► Subscribe
amiodarone hydrochloride
TABLET;ORAL075315-002Jun 30, 2000ABRXNoNo► Subscribe► Subscribe
Zydus Pharms Usa Inc
amiodarone hydrochloride
TABLET;ORAL079029-001Sep 16, 2008ABRXNoNo► Subscribe► Subscribe
Taro Pharm
amiodarone hydrochloride
TABLET;ORAL075424-002Dec 18, 2002ABRXNoNo► Subscribe► Subscribe
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