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FDA NDA · NDA020863

PLETAL

Sponsor: OTSUKA

APPLICATION
NDA020863
TYPE
NDA
ORIGINAL APPROVAL
1999-01-15
LATEST ACTION
2017-05-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PLETAL · ReferenceDiscontinued
CILOSTAZOL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PLETAL · ReferenceDiscontinued
CILOSTAZOL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2017-05-17Labeling · Supplement 24 · standard — Label ↗AP
2015-07-30Labeling · Supplement 23 · standard — Label ↗AP
2015-01-23Labeling · Supplement 22 · standard — Label ↗AP
2007-11-13Labeling · Supplement 21 · standard — Label ↗AP
2007-01-18Efficacy · Supplement 19 · standard — Label ↗AP
2005-11-23Labeling · Supplement 11 · standard — Letter ↗AP
2004-02-04Labeling · Supplement 7 · standard — Letter ↗AP
2002-09-20Manufacturing (CMC) · Supplement 8 · standardAP
2001-03-07Manufacturing (CMC) · Supplement 6 · standardAP
2000-12-27Manufacturing (CMC) · Supplement 5 · standardAP
2000-07-07Manufacturing (CMC) · Supplement 4 · standardAP
2000-06-26Manufacturing (CMC) · Supplement 3 · standardAP
2000-02-16Manufacturing (CMC) · Supplement 2 · standardAP
1999-03-31Manufacturing (CMC) · Supplement 1 · standardAP
1999-01-15Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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