ANDA 211959, held by Chartwell Rx. Clobazam.
As of Nov 14, 2026, ANDA 211959 (Clobazam), held by Chartwell Rx, was first approved by FDA on Dec 9, 2020, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 9, 2020 | Original application | Approved | None posted |
| May 1, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 8, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 9, 2020 | 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
