Manages anxiety disorders. ANDA 219882, held by Baxter Hlthcare Corp. Diazepam.
As of Nov 14, 2026, ANDA 219882 (Diazepam), held by Baxter Hlthcare Corp, was first approved by FDA on Jul 28, 2026, with 0 approved supplements and 0 published complete response letters.
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 ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 2026 | Original application | Approved | None posted |
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
