APPLICATION
NDA012882
TYPE
NDA
LATEST ACTION
1995-01-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE, TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
ISORDILDiscontinued
ISOSORBIDE DINITRATE 40MG · CAPSULE, EXTENDED RELEASE · ORAL
ISORDILDiscontinued
ISOSORBIDE DINITRATE 40MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1995-01-11Labeling · Supplement 32 · standardAP
1991-10-16Manufacturing (CMC) · Supplement 34 · standardAP
1989-07-10Manufacturing (CMC) · Supplement 33 · standardAP
1989-06-16Manufacturing (CMC) · Supplement 25 · standardAP
1989-06-16Manufacturing (CMC) · Supplement 24 · standardAP
1988-07-29Labeling · Supplement 26 · standardAP
1980-12-12Manufacturing (CMC) · Supplement 15 · standardAP
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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