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Generated: July 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022325

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NDA 022325 describes NEXTERONE, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the NEXTERONE profile page.

The generic ingredient in NEXTERONE 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: 022325

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022325

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION 022325 NDA Baxter Healthcare Corporation 43066-150 43066-150-10 100 mL in 1 BAG (43066-150-10)
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION 022325 NDA Baxter Healthcare Corporation 43066-360 43066-360-20 200 mL in 1 BAG (43066-360-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Dec 24, 2008TE:APRLD:Yes
Patent:► SubscribePatent Expiration:May 4, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150MG/100ML (1.5MG/ML)
Approval Date:Nov 16, 2010TE:RLD:Yes
Patent:► SubscribePatent Expiration:May 4, 2022Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022325

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-001Dec 24, 2008► Subscribe► Subscribe
Baxter Hlthcare
NEXTERONE
amiodarone hydrochloride
INJECTABLE;INJECTION022325-001Dec 24, 2008► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
McKesson
Queensland Health
Chubb
Baxter
Medtronic
McKinsey
Mallinckrodt
Cipla
Accenture

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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