Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022328
Company: PURDUE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTERMEZZO ZOLPIDEM TARTRATE 1.75MG TABLET;SUBLINGUAL Discontinued None Yes No
INTERMEZZO ZOLPIDEM TARTRATE 3.5MG TABLET;SUBLINGUAL Discontinued None Yes 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
11/23/2011 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/2011/022328lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022328s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022328Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022328Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/06/2019 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022328Orig1s007ltr.pdf
09/11/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022328s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022328Orig1s004ltr.pdf
11/13/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/14/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/06/2013 SUPPL-1 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022328s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/06/2019 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s007lbl.pdf
09/11/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022328s004lbl.pdf
02/06/2013 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022328s001lbl.pdf
11/23/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022328lbl.pdf

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