ANDA 77239, held by Teva Pharms. Zaleplon.
As of Nov 14, 2026, ANDA 77239 (Zaleplon), held by Teva Pharms, was first approved by FDA on Jun 6, 2008, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 6, 2008 | Original application | Approved |
| Jul 1, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| 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
