Manages anxiety disorders. ANDA 211998, held by Regcon Holdings. Diazepam.
As of Nov 14, 2026, ANDA 211998 (Diazepam), held by Regcon Holdings, was first approved by FDA on Dec 26, 2019, with 6 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 |
|---|---|---|---|
| Dec 26, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diazepam50MG/10ML (5MG/ML) · injectable;injection | Diazepam | Rx |
| Nov 12, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 8, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 10, 2021 | Supplement 6Labeling · Standard review | Approved | |
| May 21, 2021 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 21, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 8, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 26, 2019 | Original application | Approved |
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
