APPLICATION
ANDA072162
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 25MG · TABLET · ORAL
Approval history
2014-07-17Labeling · Supplement 10 · standardAP
2002-11-07Manufacturing (CMC) · Supplement 8AP
1999-11-10Manufacturing (CMC) · Supplement 7AP
1998-08-26Labeling · Supplement 6AP
1992-06-04Labeling · Supplement 5AP
1992-05-20Labeling · Supplement 4AP
1991-01-18Labeling · Supplement 3AP
1989-04-26Bioequivalence · 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.
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