ANDA 77959, held by Actavis Elizabeth. Mirtazapine.
As of Nov 15, 2026, ANDA 77959 (Mirtazapine), held by Actavis Elizabeth, was first approved by FDA on Feb 14, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 14, 2011 | Original application | Approved | None posted |
| Mirtazapine15MG · tablet, orally disintegrating;oral | Mirtazapine | Discontinued |
| Mirtazapine30MG · tablet, orally disintegrating;oral | Mirtazapine | Discontinued |
| Mirtazapine45MG · tablet, orally disintegrating;oral | Mirtazapine | Discontinued |
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
