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 |
|---|---|---|---|
| Sep 4, 1985 | Original application | Approved | None posted |
| Apr 11, 2024 | Supplement 24Labeling · Standard review | Approved | None posted |
| Apr 11, 2024 | Supplement 25Labeling · Standard review | Approved | None posted |
| Apr 11, 2024 | Supplement 27Labeling · Standard review | Approved | None posted |
| Apr 11, 2024 | Supplement 30Labeling · Standard review | Approved | None posted |
| Nov 25, 2008 | Supplement 19Labeling | Approved | None posted |
| Dec 19, 2002 | Supplement 12Labeling | Approved | None posted |
| Feb 25, 1998 | Supplement 11Manufacturing | Approved | None posted |
| Feb 5, 1998 | Supplement 10Manufacturing | Approved | None posted |
| Sep 30, 1993 | Supplement 9Manufacturing | Approved | None posted |
| May 14, 1993 | Supplement 7Labeling | Approved | None posted |
| May 14, 1993 | Supplement 31Labeling | Approved | None posted |
| Dec 29, 1989 | Supplement 4Labeling | Approved | None posted |
| Jun 19, 1989 | Supplement 5Manufacturing | Approved | None posted |
| Feb 3, 1988 | Supplement 3Manufacturing | Approved | None posted |
| Dec 8, 1986 | Supplement 2Manufacturing | Approved | None posted |
| Sep 4, 1985 | 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
