Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209376

TRALEMENT (CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE)
EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG BASE/ML;EQ 3MG BASE/ML
Marketing Status: Prescription
Active Ingredient: CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
Proprietary Name: TRALEMENT
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG BASE/ML;EQ 3MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209376
Product Number: 001
Approval Date: Jul 2, 2020
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
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