APPLICATION
ANDA072163
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-01
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MAPROTILINE HYDROCHLORIDEDiscontinued
MAPROTILINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2014-07-17Labeling · Supplement 9 · standardAP
2002-11-07Manufacturing (CMC) · Supplement 7AP
1999-11-10Manufacturing (CMC) · Supplement 6AP
1998-08-26Labeling · Supplement 5AP
1992-06-04Labeling · Supplement 4AP
1992-05-20Labeling · Supplement 3AP
1990-11-29Labeling · Supplement 2AP
1988-06-01OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.