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Serving 500+ biopharmaceutical companies globally:

Teva
Citi
Chubb
US Army
Fuji
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Harvard Business School
Covington
Dow
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Generated: June 27, 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

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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
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

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 500+ biopharmaceutical companies globally:

Mallinckrodt
Chinese Patent Office
Cipla
Boehringer Ingelheim
Fuji
McKesson
Chubb
Cantor Fitzgerald
AstraZeneca
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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