Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207768
Company: AYTU
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 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
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
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-Package Insert, Labeling-Medication Guide 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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207768s004lbl.pdf
01/13/2017 SUPPL-4 Labeling-Medication Guide 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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