Manages anxiety disorders. ANDA 76045, held by Sun Pharm Inds Ltd. Lorazepam.
As of Nov 14, 2026, ANDA 76045 (Lorazepam), held by Sun Pharm Inds Ltd, was first approved by FDA on Aug 29, 2001, with 1 approved supplement 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 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 |
|---|---|---|---|
| Aug 29, 2001 | Original application | Approved |
| Jun 29, 2009 | Supplement 7Labeling | Approved | None posted |
| Aug 29, 2001 | 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
