Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022524
Company: AQUESTIVE
Company: AQUESTIVE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ZUPLENZ | ONDANSETRON | 4MG | FILM;ORAL | Discontinued | None | Yes | No |
| ZUPLENZ | ONDANSETRON | 8MG | FILM;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/05/2021 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022524s007lbl.pdf | |
| 09/18/2014 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022524s003lbl.pdf | |
| 10/30/2013 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022524s002lbl.pdf | |
| 07/02/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022524s000lbl.pdf |