ANDA 220104, held by Micro Labs. Mirtazapine.
As of Nov 15, 2026, ANDA 220104 (Mirtazapine), held by Micro Labs, was first approved by FDA on May 19, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 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
