Manages anxiety disorders. ANDA 75731, held by Taro. Clorazepate Dipotassium.
As of Nov 15, 2026, ANDA 75731 (Clorazepate Dipotassium), held by Taro, was first approved by FDA on Apr 27, 2000, with 6 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clorazepate dipotassium 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. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2000 | Original application | Approved |
| Clorazepate Dipotassium15MG · tablet;oral | Clorazepate Dipotassium | Rx |
| Clorazepate Dipotassium7.5MG · tablet;oral | Clorazepate Dipotassium | Rx |
| Clorazepate Dipotassium3.75MG · tablet;oral | Clorazepate Dipotassium | Rx |
| Oct 17, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 17, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 17, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 20, 2013 | Supplement 5Labeling | Approved | None posted |
| Sep 27, 2011 | Supplement 3Labeling | Approved | None posted |
| Jan 20, 2010 | Supplement 2Labeling | Approved | None posted |
| Apr 27, 2000 | 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
