NDA 21412, held by Biovail Labs Intl. Zolpidem Tartrate.
As of Nov 14, 2026, NDA 21412 (Tovalt Odt), held by Biovail Labs Intl, was first approved by FDA on Apr 25, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 25, 2007 | Original applicationNew dosage form · Standard review | Approved |
| Tovalt Odt5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Zolpidem Tartrate | DiscontinuedReference drug |
| Tovalt Odt10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Zolpidem Tartrate | DiscontinuedReference drug |
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
