Treats generalized anxiety disorder (GAD). ANDA 213204, held by Unichem. Alprazolam.
As of Nov 15, 2026, ANDA 213204 (Alprazolam), held by Unichem, was first approved by FDA on Jul 13, 2026, with 0 approved supplements and 0 published complete response letters.
Alprazolam tablets are indicated for the: ● acute treatment of generalized anxiety disorder (GAD) in adults. ● treatment of panic disorder (PD), with or without agoraphobia in adults. Alprazolam tablets are a benzodiazepine indicated for the: ● Acute treatment of generalized anxiety disorder in adults. ● Treatment of panic disorder with or without agoraphobia in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2026 | Original application | Approved | None posted |
| Alprazolam0.25MG · tablet;oral | Alprazolam | Rx |
| Alprazolam0.5MG · tablet;oral | Alprazolam | Rx |
| Alprazolam1MG · tablet;oral | Alprazolam | Rx |
| Alprazolam2MG · tablet;oral | Alprazolam | Rx |
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
