Manages anxiety disorders. ANDA 215566, held by Macleods Pharms. Clorazepate Dipotassium.
As of Nov 15, 2026, ANDA 215566 (Clorazepate Dipotassium), held by Macleods Pharms, was first approved by FDA on Jun 14, 2022, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND 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 14, 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 |
| Jan 17, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 14, 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
