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FDA NDA · NDA012940

ISORDIL

Sponsor: BIOVAIL

APPLICATION
NDA012940
TYPE
NDA
ORIGINAL APPROVAL
1961-12-20
LATEST ACTION
2001-09-16
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ISORDIL · ReferenceDiscontinued
ISOSORBIDE DINITRATE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL
ISORDIL · ReferenceDiscontinued
ISOSORBIDE DINITRATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL
ISORDIL · ReferenceDiscontinued
ISOSORBIDE DINITRATE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · SUBLINGUAL

Approval history

2001-09-16Labeling · Supplement 44 · standard — Letter ↗AP
1999-06-16Labeling · Supplement 43 · standardAP
1995-01-11Labeling · Supplement 42 · standardAP
1991-10-16Manufacturing (CMC) · Supplement 41AP
1989-02-16Manufacturing (CMC) · Supplement 35AP
1988-07-29Manufacturing (CMC) · Supplement 32AP
1988-07-29Labeling · Supplement 37AP
1961-12-20Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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