APPLICATION
ANDA087564
TYPE
ANDA
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 30MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 19AP
1995-02-17Manufacturing (CMC) · Supplement 9AP
1992-04-03Manufacturing (CMC) · Supplement 13AP
1992-04-03Manufacturing (CMC) · Supplement 16AP
1992-03-16Labeling · Supplement 14AP
1991-12-19Labeling · Supplement 12AP
1990-07-25Labeling · Supplement 11AP
1990-03-07Labeling · Supplement 10AP
1987-03-31Manufacturing (CMC) · Supplement 7AP
1984-08-27Manufacturing (CMC) · Supplement 2AP
1984-07-13Manufacturing (CMC) · Supplement 1AP
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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