ANDA 77505, held by Chartwell Molecular. Zaleplon.
As of Nov 14, 2026, ANDA 77505 (Zaleplon), held by Chartwell Molecular, was first approved by FDA on Jun 20, 2008, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2008 | Original application | Approved | None posted |
| Nov 4, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 4, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 4, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 20, 2008 | Original application | Approved | None posted |
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
