← FDA DRUG APPROVALS

FDA NDA · NDA050794

VIDAZA

azacitidine

Sponsor: BRISTOL-MYERS

APPLICATION
NDA050794
TYPE
NDA
ORIGINAL APPROVAL
2004-05-19
LATEST ACTION
2024-06-28
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

VIDAZA · ReferencePrescription
AZACITIDINE 100MG/VIAL · POWDER · INTRAVENOUS, SUBCUTANEOUS

Approval history

2024-06-28Labeling · Supplement 36 · standard — Letter ↗AP
2022-09-23Labeling · Supplement 35 · standard — Label ↗AP
2022-05-20Efficacy · Supplement 34 · priority — Label ↗AP
2020-03-18Labeling · Supplement 32 · standard — Label ↗AP
2018-07-20Labeling · Supplement 31 · standard — Letter ↗AP
2017-01-30Manufacturing (CMC) · Supplement 30 · standardAP
2016-08-23Labeling · Supplement 29 · standard — Label ↗AP
2015-12-17Labeling · Supplement 28 · standard — Label ↗AP
2015-02-23Manufacturing (CMC) · Supplement 27 · priorityAP
2014-01-10Labeling · Supplement 26 · unknown — Letter ↗AP
2013-05-06Manufacturing (CMC) · Supplement 25 · priorityAP
2012-12-19Manufacturing (CMC) · Supplement 24 · priority — Label ↗AP
2012-01-24Labeling · Supplement 23 · unknown — Label ↗AP
2011-08-17Labeling · Supplement 16 · unknown — Label ↗AP
2011-08-17Labeling · Supplement 20 · unknown — Label ↗AP
2008-08-20Efficacy · Supplement 11 · priority — Label ↗AP
2008-02-22Manufacturing (CMC) · Supplement 10 — Letter ↗AP
2007-01-26Efficacy · Supplement 5 · standard — Label ↗AP
2005-06-29Labeling · Supplement 1 · standard — Letter ↗AP
2004-05-19Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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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