APPLICATION
ANDA086167
TYPE
ANDA
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISOSORBIDE DINITRATEDiscontinued
ISOSORBIDE DINITRATE 20MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 44AP
1995-02-15Manufacturing (CMC) · Supplement 43AP
1992-04-03Manufacturing (CMC) · Supplement 40AP
1992-04-03Manufacturing (CMC) · Supplement 37AP
1992-03-16Labeling · Supplement 38AP
1991-11-01Labeling · Supplement 36AP
1991-09-10Manufacturing (CMC) · Supplement 35AP
1990-07-25Labeling · Supplement 33AP
1990-07-25Labeling · Supplement 45AP
1990-03-07Labeling · Supplement 32AP
1987-04-01Manufacturing (CMC) · Supplement 30AP
1986-09-19Manufacturing (CMC) · Supplement 27AP
1986-09-19Manufacturing (CMC) · Supplement 26AP
1984-07-13Manufacturing (CMC) · Supplement 22AP
1983-12-15Manufacturing (CMC) · Supplement 21AP
1983-12-15Manufacturing (CMC) · Supplement 20AP
1982-07-20Manufacturing (CMC) · Supplement 15AP
1982-07-20Manufacturing (CMC) · Supplement 12AP
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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