APPLICATION
ANDA087545
TYPE
ANDA
LATEST ACTION
1998-12-01
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 10MG · TABLET · SUBLINGUAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 17AP
1994-10-11Manufacturing (CMC) · Supplement 15AP
1992-04-03Manufacturing (CMC) · Supplement 14AP
1992-04-03Manufacturing (CMC) · Supplement 11AP
1992-03-16Labeling · Supplement 12AP
1991-12-19Labeling · Supplement 10AP
1990-07-25Labeling · Supplement 9AP
1990-03-07Labeling · Supplement 8AP
1987-04-02Manufacturing (CMC) · Supplement 6AP
1985-08-16Manufacturing (CMC) · Supplement 3AP
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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