Treats insomnia (generally 7 to 10 days). ANDA 213003, held by Zydus Pharms. Triazolam.
As of Nov 14, 2026, ANDA 213003 (Triazolam), held by Zydus Pharms, was first approved by FDA on Dec 28, 2022, with 1 approved supplement and 0 published complete response letters.
Triazolam tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days) in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 28, 2022 | Original application | Approved | None posted |
| May 25, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 28, 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
