Relieves symptoms of depression. ANDA 72691, held by Watson Labs. Amoxapine.
As of Nov 15, 2026, ANDA 72691 (Amoxapine), held by Watson Labs, was first approved by FDA on Aug 28, 1992, with 13 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 |
|---|---|---|---|
| Aug 28, 1992 | Original application | Approved | None posted |
| Jul 17, 2014 | Supplement 36Labeling · Standard review | Approved | |
| Apr 14, 2008 | Supplement 19Labeling | Approved | None posted |
| Jul 3, 2007 | Supplement 17Labeling | Approved | None posted |
| May 5, 2005 | Supplement 13Labeling | Approved | None posted |
| Oct 23, 2002 | Supplement 9Manufacturing | Approved | None posted |
| May 7, 2002 | Supplement 10Labeling | Approved | None posted |
| Apr 25, 2001 | Supplement 7Manufacturing | Approved | None posted |
| Feb 14, 2001 | Supplement 8Labeling | Approved | None posted |
| Dec 9, 1998 | Supplement 5Manufacturing | Approved | None posted |
| Dec 13, 1995 | Supplement 4Labeling | Approved | None posted |
| Feb 7, 1994 | Supplement 3Manufacturing | Approved | None posted |
| Oct 19, 1993 | Supplement 2Labeling | Approved | None posted |
| Feb 5, 1993 | Supplement 1Labeling | Approved | None posted |
| Aug 28, 1992 | 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
