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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207768
Company: TRIS PHARMA INC

Medication Guide

Summary Review

Products on NDA 207768

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TUZISTRA XR	CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX	EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML	SUSPENSION, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207768

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207768lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207768Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207768Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207768Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207768s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207768Orig1s013ltr.pdf
06/28/2018	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207768s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207768Orig1s007ltr.pdf
08/29/2017	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207768s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207768Orig1s006ltr.pdf
01/13/2017	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207768s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207768Orig1s004ltr.pdf
02/17/2017	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
02/19/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/04/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 207768

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207768s013lbl.pdf
12/15/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207768s013lbl.pdf
06/28/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207768s007lbl.pdf
08/29/2017	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207768s006lbl.pdf
08/29/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207768s006lbl.pdf
01/13/2017	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207768s004lbl.pdf
01/13/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207768s004lbl.pdf
04/30/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207768lbl.pdf

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