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Manages anxiety disorders. ANDA 70928, held by Hikma. Diazepam.
As of Nov 13, 2026, ANDA 70928 (Diazepam), held by Hikma, was first approved by FDA on Apr 3, 1987, with 13 approved supplements and 0 published complete response letters.
First approved: Apr 3, 1987
Supplements approved: 13
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS 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.
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
