ANDA 78095, held by Upsher Smith Labs. Zaleplon.
As of Nov 14, 2026, ANDA 78095 (Zaleplon), held by Upsher Smith Labs, was first approved by FDA on Jun 6, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 6, 2008 | Original application | 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
