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FDA Drug Approval, N021064, DEFINITY RT
FDA Drug Approval, N021064, DEFINITY RT
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NDA: 021064
Company: LANTHEUS MEDCL
Drug Name: DEFINITY RT
Active Ingredients: PERFLUTREN
Strength: 13.04MG/2ML (6.52MG/ML)
Dosage Form/Route: INJECTABLE;INTRAVENOUS
Action Date: 07/31/2001
Marketing Status: Prescription
Submission Classification: Type 1 - New Molecular Entity
Company: LANTHEUS MEDCL
Drug Name: DEFINITY RT
Active Ingredients: PERFLUTREN
Strength: 13.04MG/2ML (6.52MG/ML)
Dosage Form/Route: INJECTABLE;INTRAVENOUS
Action Date: 07/31/2001
Marketing Status: Prescription
Submission Classification: Type 1 - New Molecular Entity
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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