APPLICATION
ANDA086055
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-02
LATEST ACTION
2002-07-01
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 2.5MG · TABLET · SUBLINGUAL
ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 5MG · TABLET · SUBLINGUAL
Approval history
2002-07-01Labeling · Supplement 43AP
2001-05-01Manufacturing (CMC) · Supplement 42AP
2001-03-07Manufacturing (CMC) · Supplement 40AP
2000-10-31Labeling · Supplement 41AP
1998-10-01Manufacturing (CMC) · Supplement 39AP
1997-03-03Labeling · Supplement 38AP
1994-03-02Labeling · Supplement 37AP
1993-06-16Manufacturing (CMC) · Supplement 28AP
1993-06-16Manufacturing (CMC) · Supplement 30AP
1993-06-16Labeling · Supplement 29AP
1993-06-16Manufacturing (CMC) · Supplement 31AP
1992-12-04Labeling · Supplement 36AP
1991-03-27Labeling · Supplement 35AP
1991-02-13Manufacturing (CMC) · Supplement 32AP
1988-08-24Manufacturing (CMC) · Supplement 26AP
1988-08-24Manufacturing (CMC) · Supplement 24AP
1988-08-24Manufacturing (CMC) · Supplement 25AP
1987-11-02Manufacturing (CMC) · Supplement 22AP
1987-11-02OriginalAP
1987-11-02Manufacturing (CMC) · Supplement 21AP
1987-01-07Manufacturing (CMC) · Supplement 20AP
1986-05-27Manufacturing (CMC) · Supplement 15AP
1984-08-10Manufacturing (CMC) · Supplement 16AP
1982-03-09Manufacturing (CMC) · Supplement 9AP
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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