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FDA NDA · NDA021790

DACOGEN

Sponsor: OTSUKA

APPLICATION
NDA021790
TYPE
NDA
ORIGINAL APPROVAL
2006-05-02
LATEST ACTION
2020-06-29
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DACOGEN · ReferenceDiscontinued
DECITABINE 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2020-06-29Labeling · Supplement 25 · standard — Label ↗AP
2020-02-25Labeling · Supplement 23 · standard — Label ↗AP
2018-12-21Labeling · Supplement 21 · standard — Label ↗AP
2018-12-11Labeling · Supplement 20 · standard — Label ↗AP
2016-03-08Manufacturing (CMC) · Supplement 19 · standardAP
2015-04-07Manufacturing (CMC) · Supplement 18 · standard — Label ↗AP
2014-01-15Manufacturing (CMC) · Supplement 17 · standardAP
2013-05-06Manufacturing (CMC) · Supplement 16 · standardAP
2010-03-11Efficacy · Supplement 6 · standard — Label ↗AP
2006-05-02Type 1 - New Molecular Entity · Original · standard — Review ↗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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