Nexterone Amiodarone Hydrochloride Injectable Patent Details
Summary
FDA Orange Book listing for Nexterone (Amiodarone Hydrochloride) injectable drug products under NDA 022325, held by Baxter Healthcare Corp. Three product formulations are listed: 150MG/100ML (1.5MG/ML) and 360MG/200ML (1.8MG/ML), both approved November 16, 2010 with Prescription marketing status; and 50MG/ML approved December 24, 2008 with Discontinued marketing status. All formulations are identified as Reference Listed Drugs. Patent and exclusivity information is available via linked pages for each product number.
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GovPing monitors FDA Orange Book — New Patent Listings for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 3 changes logged to date.
What changed
FDA Orange Book published a product listing for Nexterone (Amiodarone Hydrochloride) injectable formulations under NDA 022325, with Baxter Healthcare Corp as the applicant holder. The listing confirms two active prescription products (150MG/100ML and 360MG/200ML) approved in 2010, plus one discontinued formulation (50MG/ML). Each product links to separate patent and exclusivity information pages.
Manufacturers considering generic versions of amiodarone injectable products should review the linked patent pages to identify listed patents and any applicable exclusivity periods. Generic drug applicants seeking ANDA approval must address all listed patents and certify appropriately.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Product Details for NDA 022325
NEXTERONE (AMIODARONE HYDROCHLORIDE)
150MG/100ML (1.5MG/ML)
Marketing Status:
Prescription Active Ingredient: AMIODARONE HYDROCHLORIDE
Proprietary Name: NEXTERONE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 150MG/100ML (1.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N022325
Product Number: 002
Approval Date: Nov 16, 2010
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information NEXTERONE (AMIODARONE HYDROCHLORIDE)
360MG/200ML (1.8MG/ML)
Marketing Status:
Prescription Active Ingredient: AMIODARONE HYDROCHLORIDE
Proprietary Name: NEXTERONE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 360MG/200ML (1.8MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N022325
Product Number: 003
Approval Date: Nov 16, 2010
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Prescription
Patent and Exclusivity Information NEXTERONE (AMIODARONE HYDROCHLORIDE)
50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Marketing Status:
Discontinued Active Ingredient: AMIODARONE HYDROCHLORIDE
Proprietary Name: NEXTERONE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N022325
Product Number: 001
Approval Date: Dec 24, 2008
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status: Discontinued
Patent and Exclusivity Information
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