U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 209376

Expand all

MULTRYS (CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE)
EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)
Marketing Status: Prescription
Active Ingredient: CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
Proprietary Name: MULTRYS
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209376
Product Number: 003
Approval Date: Jun 30, 2021
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TRALEMENT (CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE)
EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)
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 SELENIUM/ML;EQ 3MG BASE/ML (1ML)
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
Patent and Exclusivity Information
TRALEMENT (CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE)
EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)
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 SELENIUM/ML;EQ 3MG BASE/ML (5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209376
Product Number: 002
Approval Date: Dec 2, 2020
Applicant Holder Full Name: AMERICAN REGENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top