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Generated: April 21, 2019

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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-six 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:2
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
Approval Date:Dec 24, 2008TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:May 4, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free 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 Free TrialPatent Expiration:May 4, 2022Product 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 Free Trial ➤ Try a Free Trial
Baxter Hlthcare NEXTERONE amiodarone hydrochloride INJECTABLE;INJECTION 022325-001 Dec 24, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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