Treats seizures associated with Lennox-Gastaut syndrome (LGS). ANDA 214404, held by Aurobindo Pharma Ltd. Clobazam.
As of Nov 15, 2026, ANDA 214404 (Clobazam), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 24, 2022, with 2 approved supplements and 0 published complete response letters.
Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam oral suspension is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clobazam2.5MG/ML · suspension;oral | Clobazam | Rx |
| May 15, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 26, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 24, 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
