Relieves symptoms of depression. ANDA 72879, held by Chartwell Rx. Amoxapine.
As of Nov 15, 2026, ANDA 72879 (Amoxapine), held by Chartwell Rx, was first approved by FDA on Jun 28, 1991, with 11 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Amoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. It is indicated for depression accompanied by anxiety or agitation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 28, 1991 | Original application | Approved | None posted |
| May 29, 2024 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jul 17, 2014 | Supplement 14Labeling · Standard review | Approved | None posted |
| Mar 25, 2002 | Supplement 10Manufacturing | Approved | None posted |
| May 22, 2001 | Supplement 9Labeling | Approved | None posted |
| Mar 23, 2001 | Supplement 8Manufacturing | Approved | None posted |
| Sep 18, 2000 | Supplement 7Manufacturing | Approved | None posted |
| May 5, 1999 | Supplement 6Manufacturing | Approved | None posted |
| Sep 17, 1997 | Supplement 5Manufacturing | Approved | None posted |
| Apr 10, 1995 | Supplement 4Labeling | Approved | None posted |
| Jan 24, 1994 | Supplement 3Manufacturing | Approved | None posted |
| Jul 29, 1993 | Supplement 2Labeling | Approved | None posted |
| Jun 28, 1991 | 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
