Manages anxiety disorders. ANDA 71591, held by Chartwell Rx. Lorazepam.
As of Nov 14, 2026, ANDA 71591 (Lorazepam), held by Chartwell Rx, was first approved by FDA on Oct 13, 1987, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 1987 | Original application | Approved | None posted |
| Aug 18, 2025 | Supplement 13Labeling · Standard review | Approved | None posted |
| Aug 18, 2025 | Supplement 11Labeling · Standard review | Approved | None posted |
| Feb 5, 1998 | Supplement 7Manufacturing | Approved | None posted |
| Oct 18, 1993 | Supplement 6Manufacturing | Approved | None posted |
| Jun 10, 1993 | Supplement 4Labeling | Approved | None posted |
| May 31, 1991 | Supplement 3Labeling | Approved | None posted |
| Jan 31, 1990 | Supplement 2Manufacturing | Approved | None posted |
| Oct 13, 1987 | 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
