SYMPAZAN is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older. SYMPAZAN 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 |
|---|---|---|---|
| Nov 1, 2018 | Original applicationNew dosage form · Standard review | Approved |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Jan 13, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Mar 16, 2021 | Supplement 2Labeling · Standard review | Approved | |
| Feb 5, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Dec 9, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Nov 1, 2018 | Original applicationNew dosage form · Standard review | Approved |
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
