Treats major depressive disorder (MDD). ANDA 77666, held by Apotex. Mirtazapine.
As of Nov 15, 2026, ANDA 77666 (Mirtazapine), held by Apotex, was first approved by FDA on Aug 22, 2007, with 10 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 |
|---|---|---|---|
| Aug 22, 2007 | Original application | Approved | None posted |
| Mirtazapine15MG · tablet;oral | Mirtazapine | Rx |
| Mirtazapine30MG · tablet;oral | Mirtazapine | Rx |
| Mirtazapine45MG · tablet;oral | Mirtazapine | Rx |
| Jan 7, 2021 | Supplement 14Labeling · Standard review | Approved | None posted |
| Nov 22, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Nov 22, 2019 | Supplement 11Labeling · Standard review | Approved | None posted |
| Nov 22, 2019 | Supplement 13Labeling · Standard review | Approved | None posted |
| Dec 3, 2015 | Supplement 9Labeling · Standard review | Approved | None posted |
| Aug 29, 2013 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 29, 2013 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 28, 2011 | Supplement 5Labeling | Approved | None posted |
| Jun 22, 2009 | Supplement 3Labeling | Approved | None posted |
| Nov 6, 2007 | Supplement 1Labeling | Approved | None posted |
| Aug 22, 2007 | Original application | Approved | None posted |
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
