ANDA 216008, held by Accord Hlthcare. Clobazam.
As of Nov 15, 2026, ANDA 216008 (Clobazam), held by Accord Hlthcare, was first approved by FDA on Sep 6, 2022, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 6, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clobazam2.5MG/ML · suspension;oral | Clobazam | Discontinued |
| Sep 16, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 8, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 6, 2022 | 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
