APPLICATION
ANDA086923
TYPE
ANDA
ORIGINAL APPROVAL
1987-03-12
LATEST ACTION
2025-01-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ISOSORBIDE DINITRATEPrescription
ISOSORBIDE DINITRATE 5MG · TABLET · ORAL
Approval history
2025-01-08Labeling · Supplement 39 · standardAP
2002-05-24Labeling · Supplement 33AP
1999-12-07Labeling · Supplement 32AP
1997-06-23Labeling · Supplement 31AP
1996-07-11Labeling · Supplement 30AP
1996-04-19Manufacturing (CMC) · Supplement 27AP
1991-11-01Labeling · Supplement 29AP
1988-11-29Manufacturing (CMC) · Supplement 25AP
1987-03-12OriginalAP
1985-03-29Manufacturing (CMC) · Supplement 16AP
1984-12-04Manufacturing (CMC) · Supplement 18AP
1983-11-29Manufacturing (CMC) · Supplement 12AP
1983-11-29Manufacturing (CMC) · Supplement 15AP
1983-11-29Manufacturing (CMC) · Supplement 13AP
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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