ANDA 216890, held by Breckenridge. Triazolam.
As of Nov 14, 2026, ANDA 216890 (Triazolam), held by Breckenridge, was first approved by FDA on Nov 8, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 8, 2022 | Original application | Approved | None posted |
| Aug 8, 2023 | Supplement 2Manufacturing | Approved | None posted |
| Nov 8, 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
