Manages anxiety disorders. ANDA 70303, held by Chartwell Rx. Diazepam.
As of Nov 13, 2026, ANDA 70303 (Diazepam), held by Chartwell Rx, was first approved by FDA on Dec 20, 1985, with 9 approved supplements and 0 published complete response letters.
INDICATIONS 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 1985 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diazepam5MG · tablet;oral | Diazepam | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 8, 2025 | Supplement 14Labeling · Standard review | Approved | None posted |
| May 9, 2001 | Supplement 10Manufacturing | Approved | None posted |
| Feb 9, 1995 | Supplement 9Manufacturing | Approved | None posted |
| Apr 21, 1993 | Supplement 8Labeling | Approved | None posted |
| Jul 8, 1991 | Supplement 7Manufacturing | Approved | None posted |
| Jul 18, 1988 | Supplement 6Labeling | Approved | None posted |
| Feb 23, 1988 | Supplement 2Manufacturing | Approved | None posted |
| Feb 23, 1988 | Supplement 3Manufacturing | Approved | None posted |
| Feb 23, 1988 | Supplement 4Manufacturing | Approved | None posted |
| Dec 20, 1985 | 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
