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FDA ANDA · ANDA086222

ISOSORBIDE DINITRATE

Sponsor: SANDOZ

APPLICATION
ANDA086222
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-19
LATEST ACTION
1995-03-20
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 5MG · TABLET · SUBLINGUAL

Approval history

1995-03-20Manufacturing (CMC) · Supplement 30AP
1991-05-21Labeling · Supplement 29AP
1990-02-06Labeling · Supplement 28AP
1989-11-03Labeling · Supplement 27AP
1989-06-13Labeling · Supplement 26AP
1988-02-19OriginalAP
1987-05-08Manufacturing (CMC) · Supplement 25AP
1987-05-08Manufacturing (CMC) · Supplement 23AP
1987-05-08Manufacturing (CMC) · Supplement 24AP
1986-05-14Manufacturing (CMC) · Supplement 22AP
1985-12-17Manufacturing (CMC) · Supplement 21AP
1985-12-17Manufacturing (CMC) · Supplement 13AP
1984-02-09Manufacturing (CMC) · Supplement 14AP
1983-03-28Manufacturing (CMC) · Supplement 11AP
1983-03-28Manufacturing (CMC) · Supplement 1AP
1982-06-28Manufacturing (CMC) · Supplement 12AP
1982-06-28Manufacturing (CMC) · Supplement 6AP
1982-06-28Manufacturing (CMC) · Supplement 3AP
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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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