APPLICATION
ANDA086166
TYPE
ANDA
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 5MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 38AP
1992-04-03Manufacturing (CMC) · Supplement 32AP
1992-04-03Manufacturing (CMC) · Supplement 35AP
1992-03-16Labeling · Supplement 33AP
1991-12-19Labeling · Supplement 31AP
1990-07-25Labeling · Supplement 30AP
1990-03-07Labeling · Supplement 29AP
1987-03-31Manufacturing (CMC) · Supplement 27AP
1986-09-19Manufacturing (CMC) · Supplement 24AP
1986-09-19Manufacturing (CMC) · Supplement 25AP
1986-09-19Manufacturing (CMC) · Supplement 23AP
1984-07-13Manufacturing (CMC) · Supplement 19AP
1983-11-21Manufacturing (CMC) · Supplement 17AP
1982-03-02Manufacturing (CMC) · Supplement 12AP
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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