ANDA 208825, held by Bionpharma. Clobazam.
As of Nov 14, 2026, ANDA 208825 (Clobazam), held by Bionpharma, was first approved by FDA on Oct 22, 2018, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 2018 | Original application | Approved | None posted |
| May 24, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 22, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 8, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 22, 2018 | 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
