Manages anxiety disorders. ANDA 214745, held by Fresenius Kabi USA. Diazepam.
As of Nov 13, 2026, ANDA 214745 (Diazepam), held by Fresenius Kabi USA, was first approved by FDA on Nov 10, 2022, 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 |
|---|---|---|---|
| Nov 10, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diazepam10MG/2ML (5MG/ML) · injectable;injection | Diazepam | Rx |
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
