ANDA 76219, held by Chartwell Rx. Mirtazapine.
As of Nov 15, 2026, ANDA 76219 (Mirtazapine), held by Chartwell Rx, was first approved by FDA on Jun 19, 2003, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 19, 2003 | Original application | Approved | None posted |
| Mirtazapine15MG · tablet;oral | Mirtazapine | Rx |
| Mirtazapine30MG · tablet;oral | Mirtazapine | Rx |
| Mirtazapine45MG · tablet;oral | Mirtazapine | Rx |
| Sep 23, 2022 | Supplement 28Labeling · Standard review | Approved | None posted |
| Aug 4, 2021 | Supplement 26Labeling · Standard review | Approved | None posted |
| Aug 4, 2021 | Supplement 27Labeling · Standard review | Approved | None posted |
| Feb 25, 2020 | Supplement 24Labeling · Standard review | Approved | None posted |
| Feb 25, 2020 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jan 20, 2015 | Supplement 23Labeling · Standard review | Approved | None posted |
| Aug 23, 2013 | Supplement 20Labeling · Standard review | Approved | None posted |
| May 1, 2012 | Supplement 14Labeling | Approved | None posted |
| May 1, 2012 | Supplement 15Labeling | Approved | None posted |
| Nov 5, 2007 | Supplement 10Labeling | Approved | None posted |
| Nov 5, 2007 | Supplement 12Labeling | Approved | None posted |
| Jul 21, 2006 | Supplement 5Labeling | Approved | None posted |
| Sep 26, 2005 | Supplement 3Labeling | Approved | None posted |
| Dec 29, 2004 | Supplement 2Labeling | Approved | None posted |
| Jun 19, 2003 | 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
