FDA Drug Approval, N209376, TRALEMENT
FDA Drug Approval, N209376, TRALEMENT
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NDA: 209376
Company: AM REGENT
Drug Name: TRALEMENT
Active Ingredients: CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
Strength: EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 07/02/2020
Marketing Status: Prescription
Submission Classification: Type 4 - New Combination
Company: AM REGENT
Drug Name: TRALEMENT
Active Ingredients: CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
Strength: EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 07/02/2020
Marketing Status: Prescription
Submission Classification: Type 4 - New Combination
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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