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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206323
Company: MAINPOINTE

Medication Guide

Products on NDA 206323

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TUXARIN ER	CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE	8MG;54.3MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206323

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2015	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206323s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206323Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206323Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206323s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206323Orig1s008ltr.pdf
06/28/2018	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206323s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206323Orig1s006ltr.pdf
08/29/2017	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206323Orig1s005ltr.pdf
01/13/2017	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206323Orig1s004ltr.pdf
08/25/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206323s002lbl.pdf

Labels for NDA 206323

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206323s008lbl.pdf
06/28/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206323s006lbl.pdf
08/29/2017	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s005lbl.pdf
08/29/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s005lbl.pdf
01/13/2017	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s004lbl.pdf
01/13/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s004lbl.pdf
08/25/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206323s002lbl.pdf
06/22/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206323s000lbl.pdf

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