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FDA NDA · NDA022393

ISTODAX

romidepsin

Sponsor: BRISTOL-MYERS

APPLICATION
NDA022393
TYPE
NDA
ORIGINAL APPROVAL
2009-11-05
LATEST ACTION
2021-07-30
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ISTODAX · ReferencePrescription
ROMIDEPSIN 10MG/VIAL · POWDER · INTRAVENOUS

Approval history

2021-07-30Efficacy · Supplement 17 · standard — Letter ↗AP
2021-03-24Labeling · Supplement 16 · standard — Letter ↗AP
2018-11-27Labeling · Supplement 15 · standard — Letter ↗AP
2016-07-27Labeling · Supplement 14 · standard — Label ↗AP
2014-10-15Efficacy · Supplement 13 · standard — Label ↗AP
2013-09-13Manufacturing (CMC) · Supplement 12 · standardAP
2013-06-13Labeling · Supplement 11 · standard — Letter ↗AP
2011-09-30Labeling · Supplement 6 · standard — Letter ↗AP
2011-06-16Efficacy · Supplement 4 · priority — Label ↗AP
2011-04-12Labeling · Supplement 1 · unknown — Label ↗AP
2009-11-05Type 1 - New Molecular Entity · Original · standard — 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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