APPLICATION
ANDA086034
TYPE
ANDA
ORIGINAL APPROVAL
1988-01-06
LATEST ACTION
1996-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 5MG · TABLET · ORAL
Approval history
1996-12-10Labeling · Supplement 35AP
1994-02-17Manufacturing (CMC) · Supplement 34AP
1992-11-16Labeling · Supplement 33AP
1992-04-02Labeling · Supplement 32AP
1991-12-19Labeling · Supplement 31AP
1991-09-12Labeling · Supplement 30AP
1991-08-07Manufacturing (CMC) · Supplement 28AP
1990-11-19Manufacturing (CMC) · Supplement 29AP
1990-06-29Manufacturing (CMC) · Supplement 27AP
1988-06-13Labeling · Supplement 26AP
1988-03-29Manufacturing (CMC) · Supplement 24AP
1988-03-29Manufacturing (CMC) · Supplement 25AP
1988-03-29Manufacturing (CMC) · Supplement 23AP
1988-01-06OriginalAP
1985-06-17Manufacturing (CMC) · Supplement 20AP
1985-02-25Manufacturing (CMC) · Supplement 19AP
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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