ANDA 211259, held by Pharmobedient. Clobazam.
As of Nov 14, 2026, ANDA 211259 (Clobazam), held by Pharmobedient, 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 |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clobazam2.5MG/ML · suspension;oral | Clobazam | Discontinued |
| May 1, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 11, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 19, 2019 | Supplement 1Manufacturing | 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
