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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 209376

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209376

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
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

Labels for NDA 209376

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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

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