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

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 209376
Company: AM REGENT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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) SOLUTION;INTRAVENOUS Prescription None Yes Yes
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) SOLUTION;INTRAVENOUS Prescription None Yes Yes
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) SOLUTION;INTRAVENOUS Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/02/2020 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209376s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209376Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209376Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2024 SUPPL-7 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209376Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209376Orig1s007ltr.pdf
06/30/2021 SUPPL-2 Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209376s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/209376Orig1s002.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/10/2024 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209376Orig1s007lbl.pdf
06/30/2021 SUPPL-2 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209376s002lbl.pdf
07/02/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209376s000lbl.pdf
Back to Top