ANDA 72555, held by Tp Anda Holdings. Lorazepam.
As of Nov 13, 2026, ANDA 72555 (Lorazepam), held by Tp Anda Holdings, was first approved by FDA on Mar 29, 1991, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 1991 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2007 | Supplement 23Labeling | Approved | None posted |
| Dec 31, 2002 | Supplement 14Manufacturing | Approved | None posted |
| Apr 15, 2002 | Supplement 12Manufacturing | Approved | None posted |
| Apr 15, 2002 | Supplement 13Manufacturing | Approved | None posted |
| Jan 24, 2002 | Supplement 11Manufacturing | Approved | None posted |
| Oct 2, 2000 | Supplement 9Manufacturing | Approved | None posted |
| Oct 2, 2000 | Supplement 10Labeling | Approved | None posted |
| May 16, 2000 | Supplement 7Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Dec 5, 1997 | Supplement 6Manufacturing | Approved | None posted |
| Feb 24, 1997 | Supplement 5Manufacturing | Approved | None posted |
| Aug 28, 1996 | Supplement 4Manufacturing | Approved | None posted |
| Jun 22, 1995 | Supplement 3Manufacturing | Approved | None posted |
| Jun 22, 1993 | Supplement 1Labeling | Approved | None posted |
| Mar 29, 1991 | 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
