ANDA 78526, held by Orbion Pharms. Levetiracetam.
As of Nov 15, 2026, ANDA 78526 (Levetiracetam), held by Orbion Pharms, was first approved by FDA on Jan 15, 2009, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 2009 | Original application | Approved | None posted |
| Levetiracetam250MG · tablet;oral | Levetiracetam | Rx |
| Levetiracetam500MG · tablet;oral | Levetiracetam | Rx |
| Levetiracetam750MG · tablet;oral | Levetiracetam | Rx |
| Dec 19, 2024 | Supplement 11Labeling · Standard review | Approved | None posted |
| Dec 19, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Dec 19, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Dec 19, 2024 | Supplement 14Labeling · Standard review | Approved | None posted |
| Dec 19, 2024 | Supplement 15Labeling · Standard review | Approved | None posted |
| Dec 19, 2024 | Supplement 16Labeling · Standard review | Approved | None posted |
| Dec 19, 2024 | Supplement 17Labeling · Standard review | Approved | None posted |
| Dec 9, 2014 | Supplement 7Labeling | Approved | None posted |
| Dec 9, 2014 | Supplement 9Labeling · Standard review | Approved | None posted |
| Dec 9, 2014 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 12, 2012 | Supplement 6REMS | Approved | None posted |
| Sep 27, 2011 | Supplement 5Labeling | Approved | None posted |
| Oct 27, 2010 | Supplement 3Labeling | Approved | None posted |
| Oct 27, 2010 | Supplement 4Labeling | Approved | None posted |
| Aug 20, 2009 | Supplement 1Labeling | Approved | None posted |
| Jan 15, 2009 | 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
