ANDA 203581, held by Chartwell Rx. Glyburide.
As of Nov 14, 2026, ANDA 203581 (Glyburide), held by Chartwell Rx, was first approved by FDA on Apr 14, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 14, 2016 | 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
