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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021064

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DEFINITY (PERFLUTREN)
6.52MG/ML
Marketing Status: Prescription
Active Ingredient: PERFLUTREN
Proprietary Name: DEFINITY
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 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)
6.52MG/ML
Marketing Status: Prescription
Active Ingredient: PERFLUTREN
Proprietary Name: DEFINITY RT
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 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
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