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Manages anxiety disorders. ANDA 70313, held by Hikma. Diazepam.
As of Nov 13, 2026, ANDA 70313 (Diazepam), held by Hikma, was first approved by FDA on Dec 16, 1985, with 23 approved supplements and 0 published complete response letters.
First approved: Dec 16, 1985
Supplements approved: 23
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient’s recall of the procedures (see WARNINGS ).
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
