APPLICATION
NDA017543
TYPE
NDA
ORIGINAL APPROVAL
1980-12-01
LATEST ACTION
1997-04-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LUDIOMILDiscontinued
MAPROTILINE HYDROCHLORIDE 50MG · TABLET · ORAL
LUDIOMILDiscontinued
MAPROTILINE HYDROCHLORIDE 75MG · TABLET · ORAL
LUDIOMILDiscontinued
MAPROTILINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
1997-04-10Labeling · Supplement 26AP
1997-04-10Labeling · Supplement 18AP
1997-04-10Labeling · Supplement 30 · standardAP
1997-04-10Labeling · Supplement 29 · standardAP
1997-04-10Labeling · Supplement 19AP
1997-04-10Labeling · Supplement 21AP
1996-03-05Manufacturing (CMC) · Supplement 28 · standardAP
1994-11-28Manufacturing (CMC) · Supplement 27 · standardAP
1994-06-28Manufacturing (CMC) · Supplement 24 · standardAP
1993-07-12Manufacturing (CMC) · Supplement 25 · standardAP
1990-03-27Manufacturing (CMC) · Supplement 22 · standardAP
1989-04-07Manufacturing (CMC) · Supplement 20 · standardAP
1985-04-26Labeling · Supplement 16AP
1985-03-21Manufacturing (CMC) · Supplement 17 · standardAP
1983-11-04Manufacturing (CMC) · Supplement 15 · standardAP
1983-06-16Labeling · Supplement 14AP
1983-01-12Labeling · Supplement 9AP
1982-11-17Labeling · Supplement 12AP
1982-11-08Labeling · Supplement 11AP
1982-10-21Manufacturing (CMC) · Supplement 10 · standardAP
1982-09-30Manufacturing (CMC) · Supplement 2 · standardAP
1981-08-03Manufacturing (CMC) · Supplement 7 · standardAP
1981-08-03Manufacturing (CMC) · Supplement 5 · standardAP
1981-08-03Manufacturing (CMC) · Supplement 8 · standardAP
1981-08-03Manufacturing (CMC) · Supplement 6 · standardAP
1981-08-03Labeling · Supplement 4AP
1981-05-29Efficacy · Supplement 1AP
1980-12-01Type 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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