APPLICATION
ANDA089367
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-07
LATEST ACTION
2020-02-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 20MG · TABLET · ORAL
Approval history
2020-02-20Labeling · Supplement 23 · standardAP
2008-02-21Labeling · Supplement 18AP
2001-06-07Manufacturing (CMC) · Supplement 15AP
1999-09-22Labeling · Supplement 14AP
1999-05-05Manufacturing (CMC) · Supplement 12AP
1999-03-25Manufacturing (CMC) · Supplement 9AP
1999-03-25Labeling · Supplement 10AP
1999-03-11Manufacturing (CMC) · Supplement 11AP
1996-12-02Manufacturing (CMC) · Supplement 8AP
1996-09-13Labeling · Supplement 7AP
1996-02-27Manufacturing (CMC) · Supplement 6AP
1995-03-20Manufacturing (CMC) · Supplement 5AP
1991-05-21Labeling · Supplement 4AP
1989-11-03Labeling · Supplement 2AP
1989-07-19Labeling · Supplement 1AP
1988-04-07OriginalAP
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.