Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206323
Company: MAINPOINTE
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
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
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-Package Insert, Labeling-Container/Carton Labels 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-Package Insert, Labeling-Container/Carton Labels 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s005lbl.pdf
08/29/2017 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s005lbl.pdf
01/13/2017 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s004lbl.pdf
01/13/2017 SUPPL-4 Labeling-Container/Carton Labels 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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