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FDA NDA · NDA020225

IMDUR

Sponsor: SCHERING PLOUGH

APPLICATION
NDA020225
TYPE
NDA
ORIGINAL APPROVAL
1993-08-12
LATEST ACTION
2003-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

IMDUR · ReferenceDiscontinued
ISOSORBIDE MONONITRATE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
IMDUR · ReferenceDiscontinued
ISOSORBIDE MONONITRATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
IMDUR · ReferenceDiscontinued
ISOSORBIDE MONONITRATE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2003-01-22Labeling · Supplement 8 · standard — Letter ↗AP
1999-02-17Labeling · Supplement 7 · standardAP
1999-01-27Manufacturing (CMC) · Supplement 5 · standardAP
1998-12-18Manufacturing (CMC) · Supplement 6 · standardAP
1998-01-23Manufacturing (CMC) · Supplement 3 · standardAP
1997-12-17Labeling · Supplement 4 · standardAP
1996-03-06Labeling · Supplement 2 · standardAP
1995-03-30Manufacturing (CMC) · Supplement 1 · standardAP
1993-08-12Type 3 - New Dosage Form · Original · standardAP
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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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