ANDA 74974, held by Epic Pharma LLC. Lorazepam.
As of Nov 13, 2026, ANDA 74974 (Lorazepam), held by Epic Pharma LLC, was first approved by FDA on Jul 23, 1998, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lorazepam2MG/ML ยท injectable;injection | Lorazepam | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 5, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Apr 28, 2000 | Supplement 3Manufacturing | Approved | None posted |
| Jun 7, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Jul 23, 1998 | 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
