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FDA NDA · NDA204886

ZONTIVITY

Sponsor: KEY THERAP

APPLICATION
NDA204886
TYPE
NDA
ORIGINAL APPROVAL
2014-05-08
LATEST ACTION
2019-11-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZONTIVITY · ReferenceDiscontinued
VORAPAXAR SULFATE EQ 2.08MG BASE · TABLET · ORAL

Approval history

2019-11-07Labeling · Supplement 5 · standard — Letter ↗AP
2015-07-14Manufacturing (CMC) · Supplement 1 · standardAP
2015-04-16Labeling · Supplement 2 · standard — Label ↗AP
2014-05-08Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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