Tools / Drug approvals and letters / Drugs Asendin NDA 18021, held by Lederle . Amoxapine
As of Nov 15, 2026, NDA 18021 (Asendin), held by Lederle, was first approved by FDA on Sep 22, 1980, with 36 approved supplements and 0 published complete response letters.
First approved : Sep 22, 1980 Review : Standard Supplements approved : 36 Complete response letters : 0
Approvals and New Uses The original application and every efficacy supplement, newest first; all 37 submissions below Date Submission Status Documents Sep 22, 1980 Original applicationNew molecular entity · Standard review Approved None posted
Products 4 strengths and forms Product Active ingredient Marketing Asendin25MG · tablet;oral Amoxapine Discontinued Asendin50MG · tablet;oral Amoxapine Discontinued Asendin100MG · tablet;oral Amoxapine Discontinued Asendin150MG · tablet;oral Amoxapine Discontinued
All 37 submissions, including labeling and manufacturing supplements Date Submission Status Documents Sep 25, 2001 Supplement 41Labeling · Standard review Approved None posted Apr 6, 2000 Supplement 28Labeling · Standard review Approved None posted Apr 6, 2000 Supplement 16Labeling · Standard review Approved None posted Apr 6, 2000 Supplement 33Labeling · Standard review Approved None posted Apr 6, 2000 Supplement 37Labeling · Standard review Approved None posted Mar 5, 1999 Supplement 38Manufacturing · Standard review Approved None posted Mar 4, 1999 Supplement 40Manufacturing · Standard review Approved None posted May 14, 1997 Supplement 36Manufacturing · Standard review Approved None posted Feb 6, 1997 Supplement 35Manufacturing · Standard review Approved None posted Aug 29, 1996 Supplement 34Manufacturing · Standard review Approved None posted May 3, 1995 Supplement 32Manufacturing · Standard review Approved None posted Mar 29, 1994 Supplement 31Manufacturing · Standard review Approved None posted Jan 3, 1991 Supplement 30Manufacturing · Standard review Approved None posted Feb 18, 1988 Supplement 27Labeling · Standard review Approved None posted Feb 18, 1988 Supplement 24Labeling · Standard review Approved None posted Feb 18, 1988 Supplement 22Labeling · Standard review Approved None posted Feb 18, 1988 Supplement 21REMS · Standard review Approved None posted Jul 30, 1987 Supplement 26Labeling · Standard review Approved None posted Jun 4, 1987 Supplement 25Manufacturing · Standard review Approved None posted Oct 20, 1986 Supplement 23Manufacturing · Standard review Approved None posted Jun 6, 1985 Supplement 19Labeling · Standard review Approved None posted Feb 26, 1985 Supplement 18Manufacturing · Standard review Approved None posted Dec 13, 1984 Supplement 17Manufacturing · Standard review Approved None posted Aug 23, 1983 Supplement 14Manufacturing · Standard review Approved None posted May 4, 1983 Supplement 11Manufacturing · Standard review Approved None posted Jan 25, 1983 Supplement 13Labeling · Standard review Approved None posted Oct 4, 1982 Supplement 12Labeling · Standard review Approved None posted May 18, 1982 Supplement 10Manufacturing · Standard review Approved None posted Jan 12, 1982 Supplement 9Labeling · Standard review Approved None posted Dec 22, 1981 Supplement 7Manufacturing · Standard review Approved None posted Jun 22, 1981 Supplement 6Manufacturing · Standard review Approved None posted Jun 22, 1981 Supplement 5Labeling · Standard review Approved None posted Apr 13, 1981 Supplement 3Manufacturing · Standard review Approved None posted Feb 17, 1981 Supplement 4Manufacturing · Standard review Approved None posted Feb 9, 1981 Supplement 2Manufacturing · Standard review Approved None posted Feb 9, 1981 Supplement 1Manufacturing · Standard review Approved None posted Sep 22, 1980 Original applicationNew molecular entity · Standard review Approved None posted
Identifiers
Application NDA 18021 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
