Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Manages anxiety disorders. ANDA 72755, held by Hikma. Lorazepam.
As of Nov 13, 2026, ANDA 72755 (Lorazepam Intensol), held by Hikma, was first approved by FDA on Jun 28, 1991, with 8 approved supplements and 0 published complete response letters.
First approved: Jun 28, 1991
Supplements approved: 8
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Lorazepam is 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.
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
