Treats partial-onset seizures. ANDA 202958, held by Apotex. Levetiracetam.
As of Nov 15, 2026, ANDA 202958 (Levetiracetam), held by Apotex, was first approved by FDA on Feb 25, 2015, with 9 approved supplements and 0 published complete response letters.
Levetiracetam extended-release tablets are indicated for the treatment of partial-onset seizures in patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam1GM · tablet, extended release;oral | Levetiracetam | Discontinued |
| Oct 9, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 9, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 23, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 25, 2015 | Original application | 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
