U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 021064

Expand all

DEFINITY (PERFLUTREN)
13.04MG/2ML (6.52MG/ML)
Marketing Status: Prescription
Active Ingredient: PERFLUTREN
Proprietary Name: DEFINITY
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 13.04MG/2ML (6.52MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021064
Product Number: 001
Approval Date: Jul 31, 2001
Applicant Holder Full Name: LANTHEUS MEDICAL IMAGING INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DEFINITY RT (PERFLUTREN)
13.04MG/2ML (6.52MG/ML)
Marketing Status: Prescription
Active Ingredient: PERFLUTREN
Proprietary Name: DEFINITY RT
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 13.04MG/2ML (6.52MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021064
Product Number: 002
Approval Date: Nov 17, 2020
Applicant Holder Full Name: LANTHEUS MEDICAL IMAGING INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top