General MedicationsINTRAVENOUSStandard

TRALEMENT

CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE

Standard Dose

EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview TRALEMENT is listed in Drugs@FDA under application 209376 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE Form and strength SOLUTION;INTRAVENOUS - EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML) Sponsor AM REGENT Submission history Latest submission status date: 2024-07-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview TRALEMENT is listed in Drugs@FDA under application 209376 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE Form and strength SOLUTION;INTRAVENOUS - EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML) Sponsor AM REGENT Submission history Latest submission status date: 2024-07-10 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.