You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for New Drug Application (NDA): 022325


✉ Email this page to a colleague

« Back to Dashboard


NDA 022325 describes NEXTERONE, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from two suppliers. There is one patent 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-two suppliers are listed for this compound. Additional details are available on the amiodarone hydrochloride profile page.
Summary for 022325
Tradename:NEXTERONE
Applicant:Baxter Hlthcare
Ingredient:amiodarone hydrochloride
Patents:1
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)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Dec 24, 2008TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength150MG/100ML (1.5MG/ML)
Approval Date:Nov 16, 2010TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength360MG/200ML (1.8MG/ML)
Approval Date:Nov 16, 2010TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022325

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-003 Nov 16, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.