Manages anxiety disorders. ANDA 213730, held by Novitium Pharma. Clorazepate Dipotassium.
As of Nov 15, 2026, ANDA 213730 (Clorazepate Dipotassium), held by Novitium Pharma, was first approved by FDA on Jun 16, 2022, with 1 approved supplement and 0 published complete response letters.
INDICATIONS & USAGE Clorazepate dipotassium 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. 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 |
|---|---|---|---|
| Jun 16, 2022 | Original application | Approved | None posted |
| Clorazepate Dipotassium3.75MG · tablet;oral | Clorazepate Dipotassium | Rx |
| Clorazepate Dipotassium7.5MG · tablet;oral | Clorazepate Dipotassium | Rx |
| Clorazepate Dipotassium15MG · tablet;oral | Clorazepate Dipotassium | Rx |
| Jun 28, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 16, 2022 | 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
