Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022328
Company: PURDUE PHARMA
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 |
---|---|---|---|---|---|
08/18/2019 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022328Orig1s008ltr.pdf | |
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 |
---|---|---|---|---|---|
08/18/2019 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022328s008lbl.pdf | |
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 |