Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 022325

Expand all

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50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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