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FDA ANDA · ANDA086225

ISOSORBIDE DINITRATE

Sponsor: SANDOZ

APPLICATION
ANDA086225
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 2.5MG · TABLET · SUBLINGUAL

Approval history

1995-03-20Manufacturing (CMC) · Supplement 28AP
1991-05-21Labeling · Supplement 27AP
1990-02-06Labeling · Supplement 26AP
1989-11-03Labeling · Supplement 25AP
1989-06-13Labeling · Supplement 24AP
1988-02-19OriginalAP
1987-04-29Manufacturing (CMC) · Supplement 22AP
1987-04-29Manufacturing (CMC) · Supplement 23AP
1987-04-29Manufacturing (CMC) · Supplement 21AP
1986-05-14Manufacturing (CMC) · Supplement 20AP
1984-02-09Manufacturing (CMC) · Supplement 12AP
1983-04-29Manufacturing (CMC) · Supplement 8AP
1983-04-29Manufacturing (CMC) · Supplement 4AP
1983-04-29Manufacturing (CMC) · Supplement 10AP
1983-04-29Manufacturing (CMC) · Supplement 9AP
1983-04-29Manufacturing (CMC) · Supplement 1AP
VIEW ON DRUGS@FDA ↗

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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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