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 |
| 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 |