Treats partial-onset seizures. ANDA 91261, held by Apotex Inc. Levetiracetam.
As of Nov 15, 2026, ANDA 91261 (Levetiracetam), held by Apotex Inc, was first approved by FDA on Sep 12, 2011, with 11 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 |
|---|---|---|---|
| Sep 12, 2011 | Original application | Approved |
| Levetiracetam500MG · tablet, extended release;oral | Levetiracetam | Rx |
| Levetiracetam750MG · tablet, extended release;oral | Levetiracetam | Rx |
| Oct 9, 2024 | Supplement 19Labeling · Standard review | Approved | None posted |
| Oct 9, 2024 | Supplement 18Labeling · Standard review | Approved | None posted |
| Apr 23, 2024 | Supplement 15Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Sep 10, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 12, 2011 | 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
