NDA 22196, held by Aytu. Zolpidem Tartrate.
As of Nov 14, 2026, NDA 22196 (Zolpimist), held by Aytu, was first approved by FDA on Dec 19, 2008, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2008 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zolpimist5MG/SPRAY · spray, metered;oral | Zolpidem Tartrate | DiscontinuedReference drug |
| Nov 9, 2026 | Supplement 13Labeling · Standard review | Approved | |
| Aug 18, 2019 | Supplement 12Labeling | Approved | |
| Feb 6, 2019 | Supplement 11Labeling | Approved | |
| Sep 28, 2011 | Supplement 7REMS | Approved | |
| Oct 11, 2010 | Supplement 3REMS | Approved | |
| Dec 19, 2008 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
