Treats major depressive disorder (MDD). ANDA 76122, held by Mylan. Mirtazapine.
As of Nov 15, 2026, ANDA 76122 (Mirtazapine), held by Mylan, was first approved by FDA on Jun 19, 2003, with 13 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 |
|---|---|---|---|
| Jun 19, 2003 | Original application | Approved |
| Mirtazapine15MG · tablet;oral | Mirtazapine | Rx |
| Mirtazapine30MG · tablet;oral | Mirtazapine | Rx |
| Mirtazapine45MG · tablet;oral | Mirtazapine | Rx |
| Sep 15, 2022 | Supplement 29Labeling · Standard review | Approved | None posted |
| Nov 4, 2020 | Supplement 27Labeling · Standard review | Approved | None posted |
| Nov 4, 2020 | Supplement 26Labeling · Standard review | Approved | None posted |
| Nov 22, 2019 | Supplement 25Labeling · Standard review | Approved | None posted |
| Nov 22, 2019 | Supplement 24Labeling · Standard review | Approved | None posted |
| Nov 22, 2019 | Supplement 22Labeling · Standard review | Approved | None posted |
| Aug 27, 2015 | Supplement 21Labeling · Standard review | Approved | None posted |
| Mar 18, 2014 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jun 28, 2011 | Supplement 14Labeling | Approved | None posted |
| Nov 6, 2007 | Supplement 10Labeling | Approved | None posted |
| Nov 6, 2007 | Supplement 9Labeling | Approved | None posted |
| Sep 26, 2005 | Supplement 2Labeling | Approved | None posted |
| Dec 29, 2004 | Supplement 1Labeling | Approved | None posted |
| Jun 19, 2003 | Original application | Approved |
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
