APPLICATION
NDA019091
TYPE
NDA
ORIGINAL APPROVAL
1991-12-30
LATEST ACTION
2000-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISMODiscontinued
ISOSORBIDE MONONITRATE 20MG · TABLET · ORAL
Approval history
2000-06-13Labeling · Supplement 8 · standardAP
1999-06-16Labeling · Supplement 7 · standardAP
1998-01-13Manufacturing (CMC) · Supplement 6 · standardAP
1997-01-10Labeling · Supplement 5 · standardAP
1994-04-08Manufacturing (CMC) · Supplement 4 · standardAP
1993-12-20Manufacturing (CMC) · Supplement 2 · standardAP
1993-01-26Manufacturing (CMC) · Supplement 1 · standardAP
1991-12-30Type 1 - New Molecular Entity · Original · standardAP
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.