APPLICATION
ANDA088088
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-02
LATEST ACTION
2020-05-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 10MG · TABLET · ORAL
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 5MG · TABLET · ORAL
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 20MG · TABLET · ORAL
Approval history
2020-05-12Manufacturing (CMC) · Supplement 41 · unknownAP
2016-01-04Labeling · Supplement 34 · standardAP
2016-01-04Labeling · Supplement 33 · standardAP
2007-03-30Manufacturing (CMC) · Supplement 28AP
2002-07-05Labeling · Supplement 26AP
2001-04-11Manufacturing (CMC) · Supplement 25AP
2001-03-07Manufacturing (CMC) · Supplement 23AP
2000-04-17Labeling · Supplement 24AP
1998-10-01Manufacturing (CMC) · Supplement 22AP
1997-12-17Manufacturing (CMC) · Supplement 21AP
1997-03-03Labeling · Supplement 20AP
1994-04-12Manufacturing (CMC) · Supplement 18AP
1994-04-12Labeling · Supplement 19AP
1993-06-16Manufacturing (CMC) · Supplement 12AP
1993-06-16Manufacturing (CMC) · Supplement 10AP
1993-06-16Labeling · Supplement 9AP
1993-06-16Manufacturing (CMC) · Supplement 11AP
1993-02-09Manufacturing (CMC) · Supplement 14AP
1993-02-09Manufacturing (CMC) · Supplement 15AP
1992-12-04Labeling · Supplement 17AP
1991-05-13Labeling · Supplement 16AP
1991-02-13Manufacturing (CMC) · Supplement 13AP
1988-10-14Labeling · Supplement 8AP
1987-11-02OriginalAP
1984-08-10Manufacturing (CMC) · Supplement 1AP
1984-05-11Manufacturing (CMC) · Supplement 2AP
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.