Treats major depressive disorder (MDD). ANDA 219721, held by Annora Pharma. Mirtazapine.
As of Nov 15, 2026, ANDA 219721 (Mirtazapine), held by Annora Pharma, was first approved by FDA on Oct 2, 2025, with 0 approved supplements and 0 published complete response letters.
Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 2, 2025 | Original application | Approved | None posted |
| Mirtazapine7.5MG · tablet;oral | Mirtazapine | Rx |
| Mirtazapine15MG · tablet;oral | Mirtazapine | Rx |
| Mirtazapine30MG · tablet;oral | Mirtazapine | Rx |
| Mirtazapine45MG · tablet;oral | Mirtazapine | 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
