APPLICATION
ANDA086031
TYPE
ANDA
ORIGINAL APPROVAL
1987-09-29
LATEST ACTION
1996-12-10
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL
Approval history
1996-12-10Labeling · Supplement 30AP
1992-08-25Labeling · Supplement 29AP
1992-04-02Labeling · Supplement 28AP
1991-09-12Labeling · Supplement 27AP
1991-08-07Manufacturing (CMC) · Supplement 25AP
1991-02-13Manufacturing (CMC) · Supplement 23AP
1991-02-13Manufacturing (CMC) · Supplement 22AP
1990-11-19Manufacturing (CMC) · Supplement 26AP
1990-06-29Manufacturing (CMC) · Supplement 21AP
1988-06-13Labeling · Supplement 20AP
1987-09-29OriginalAP
1985-06-17Manufacturing (CMC) · Supplement 17AP
1985-02-25Manufacturing (CMC) · Supplement 16AP
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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