Manages anxiety disorders. ANDA 217843, held by Aurobindo Pharma Ltd. Diazepam.
As of Nov 13, 2026, ANDA 217843 (Diazepam), held by Aurobindo Pharma Ltd, was first approved by FDA on Dec 14, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Diazepam tablets are 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 tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 14, 2023 | Original application | Approved | None posted |
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
