Manages anxiety disorders. ANDA 203572, held by Aurobindo Pharma. Lorazepam.
As of Nov 13, 2026, ANDA 203572 (Lorazepam), held by Aurobindo Pharma, was first approved by FDA on Dec 22, 2017, with 2 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 |
|---|---|---|---|
| Dec 22, 2017 | Original application | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 27, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 22, 2017 | 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
