APPLICATION
NDA018021
TYPE
NDA
ORIGINAL APPROVAL
1980-09-22
LATEST ACTION
2001-09-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ASENDINDiscontinued
AMOXAPINE 50MG · TABLET · ORAL
ASENDINDiscontinued
AMOXAPINE 100MG · TABLET · ORAL
ASENDINDiscontinued
AMOXAPINE 25MG · TABLET · ORAL
ASENDINDiscontinued
AMOXAPINE 150MG · TABLET · ORAL
Approval history
2001-09-25Labeling · Supplement 41 · standardAP
2000-04-06Labeling · Supplement 33 · standardAP
2000-04-06Labeling · Supplement 28 · standardAP
2000-04-06Labeling · Supplement 16 · standardAP
2000-04-06Labeling · Supplement 37 · standardAP
1999-03-05Manufacturing (CMC) · Supplement 38 · standardAP
1999-03-04Manufacturing (CMC) · Supplement 40 · standardAP
1997-05-14Manufacturing (CMC) · Supplement 36 · standardAP
1997-02-06Manufacturing (CMC) · Supplement 35 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 34 · standardAP
1995-05-03Manufacturing (CMC) · Supplement 32 · standardAP
1994-03-29Manufacturing (CMC) · Supplement 31 · standardAP
1991-01-03Manufacturing (CMC) · Supplement 30 · standardAP
1988-02-18Labeling · Supplement 27 · standardAP
1988-02-18REMS · Supplement 21 · standardAP
1988-02-18Labeling · Supplement 24 · standardAP
1988-02-18Labeling · Supplement 22 · standardAP
1987-07-30Labeling · Supplement 26 · standardAP
1987-06-04Manufacturing (CMC) · Supplement 25 · standardAP
1986-10-20Manufacturing (CMC) · Supplement 23 · standardAP
1985-06-06Labeling · Supplement 19 · standardAP
1985-02-26Manufacturing (CMC) · Supplement 18 · standardAP
1984-12-13Manufacturing (CMC) · Supplement 17 · standardAP
1983-08-23Manufacturing (CMC) · Supplement 14 · standardAP
1983-05-04Manufacturing (CMC) · Supplement 11 · standardAP
1983-01-25Labeling · Supplement 13 · standardAP
1982-10-04Labeling · Supplement 12 · standardAP
1982-05-18Manufacturing (CMC) · Supplement 10 · standardAP
1982-01-12Labeling · Supplement 9 · standardAP
1981-12-22Manufacturing (CMC) · Supplement 7 · standardAP
1981-06-22Manufacturing (CMC) · Supplement 6 · standardAP
1981-06-22Labeling · Supplement 5 · standardAP
1981-04-13Manufacturing (CMC) · Supplement 3 · standardAP
1981-02-17Manufacturing (CMC) · Supplement 4 · standardAP
1981-02-09Manufacturing (CMC) · Supplement 1 · standardAP
1981-02-09Manufacturing (CMC) · Supplement 2 · standardAP
1980-09-22Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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