Treats generalized anxiety disorder. ANDA 78088, held by Ph Health. Alprazolam.
As of Nov 15, 2026, ANDA 78088 (Alprazolam), held by Ph Health, was first approved by FDA on Jan 9, 2009, with 5 approved supplements and 0 published complete response letters.
1.1 Generalized Anxiety Disorder Alprazolam orally disintegrating tablets, USP are indicated for the treatment of generalized anxiety disorder. The efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled trials. 1.2 Panic Disorder Alprazolam orally disintegrating tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 9, 2009 | Original application | Approved |
| Alprazolam0.25MG · tablet, orally disintegrating;oral | Alprazolam | Rx |
| Alprazolam0.5MG · tablet, orally disintegrating;oral | Alprazolam | Rx |
| Alprazolam1MG · tablet, orally disintegrating;oral | Alprazolam | Rx |
| Alprazolam2MG · tablet, orally disintegrating;oral | Alprazolam | Rx |
| Jan 17, 2023 | Supplement 15Labeling · Standard review | Approved | None posted |
| Feb 5, 2021 | Supplement 13Labeling · Standard review | Approved | None posted |
| Dec 16, 2016 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 28, 2016 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 27, 2011 | Supplement 3Labeling | Approved | None posted |
| Jan 9, 2009 | 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
