Treats major depressive disorder (MDD). ANDA 219919, held by Novitium Pharma. Mirtazapine.
As of Nov 15, 2026, ANDA 219919 (Mirtazapine), held by Novitium Pharma, was first approved by FDA on Feb 2, 2026, 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 |
|---|---|---|---|
| Feb 2, 2026 | 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
