Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021997
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EDLUAR | ZOLPIDEM TARTRATE | 5MG | TABLET;SUBLINGUAL | Prescription | AB | Yes | No |
| EDLUAR | ZOLPIDEM TARTRATE | 10MG | TABLET;SUBLINGUAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/18/2019 | SUPPL-11 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021997s011lbl.pdf | |
| 02/06/2019 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021997s010lbl.pdf | |
| 10/24/2018 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021997s008lbl.pdf | |
| 10/29/2014 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021997s006lbl.pdf | |
| 10/29/2014 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021997s006lbl.pdf | |
| 04/19/2013 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021997s005lbl.pdf | |
| 03/13/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021997lbl.pdf |