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FDA NDA · NDA012093

ISOSORBIDE DINITRATE

Sponsor: BAUSCH

APPLICATION
NDA012093
TYPE
NDA
ORIGINAL APPROVAL
1959-11-09
LATEST ACTION
2015-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

ISORDIL · ReferencePrescription
ISOSORBIDE DINITRATE 5MG · TABLET · ORAL
ISORDIL · ReferenceDiscontinued
ISOSORBIDE DINITRATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ISORDIL · ReferencePrescription
ISOSORBIDE DINITRATE 40MG · TABLET · ORAL
ISORDIL · ReferenceDiscontinued
ISOSORBIDE DINITRATE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ISORDIL · ReferenceDiscontinued
ISOSORBIDE DINITRATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2015-01-14Labeling · Supplement 52 · standard — Letter ↗AP
2014-11-20Manufacturing (CMC) · Supplement 51AP
2001-09-26Labeling · Supplement 44 · standard — Letter ↗AP
1999-06-16Labeling · Supplement 43 · standardAP
1995-01-11Labeling · Supplement 41AP
1991-10-16Manufacturing (CMC) · Supplement 42AP
1989-02-16Manufacturing (CMC) · Supplement 34AP
1988-07-29Labeling · Supplement 37AP
1959-11-09Type 1 - New Molecular Entity · Original · priorityAP
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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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