ANDA 78826, held by Amneal Pharms. Lorazepam.
As of Nov 13, 2026, ANDA 78826 (Lorazepam), held by Amneal Pharms, was first approved by FDA on Jun 23, 2010, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2010 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 2012 | Supplement 1Manufacturing | Approved | None posted |
| Jun 23, 2010 | 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
