← FDA DRUG APPROVALS

FDA NDA · NDA021602

VELCADE

bortezomib

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA021602
TYPE
NDA
ORIGINAL APPROVAL
2003-05-13
LATEST ACTION
2021-11-04
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VELCADE · ReferencePrescription
BORTEZOMIB 3.5MG/VIAL · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS

Approval history

2021-11-04Labeling · Supplement 46 · standard — Letter ↗AP
2021-10-25Labeling · Supplement 45 · standard — Letter ↗AP
2019-04-25Efficacy · Supplement 44 · standard — Letter ↗AP
2017-06-09Labeling · Supplement 43 · standard — Label ↗AP
2015-09-14Efficacy · Supplement 42 · priority — Label ↗AP
2015-08-20Manufacturing (CMC) · Supplement 41 · priorityAP
2014-10-08Efficacy · Supplement 40 · priority — Label ↗AP
2014-09-08Manufacturing (CMC) · Supplement 39 · priorityAP
2014-08-08Efficacy · Supplement 38 · standard — Letter ↗AP
2014-03-13Manufacturing (CMC) · Supplement 37 · priorityAP
2013-08-05Manufacturing (CMC) · Supplement 36 · priorityAP
2013-08-02Manufacturing (CMC) · Supplement 35 · priorityAP
2013-04-01Manufacturing (CMC) · Supplement 33 · priorityAP
2012-10-26Labeling · Supplement 31 · unknown — Label ↗AP
2012-10-26Labeling · Supplement 32 · unknown — Label ↗AP
2012-01-23Efficacy · Supplement 27 · standard — Label ↗AP
2011-11-01Efficacy · Supplement 30 · standard — Label ↗AP
2011-11-01Labeling · Supplement 29 · unknown — Label ↗AP
2011-04-07Labeling · Supplement 28 · unknownAP
2010-12-03Labeling · Supplement 23 · unknown — Label ↗AP
2009-12-30Efficacy · Supplement 20 · priority — Letter ↗AP
2009-12-30Efficacy · Supplement 19 · standard — Label ↗AP
2009-04-24Manufacturing (CMC) · Supplement 18 — Letter ↗AP
2008-06-20Efficacy · Supplement 15 · priority — Label ↗AP
2007-10-10Efficacy · Supplement 13 · standard — Letter ↗AP
2006-12-08Efficacy · Supplement 10 · priority — Letter ↗AP
2006-05-31Labeling · Supplement 9 · standard — Label ↗AP
2005-12-08Labeling · Supplement 7 · standard — Letter ↗AP
2005-03-25Efficacy · Supplement 6 · priority — Letter ↗AP
2004-05-25Labeling · Supplement 4 · standard — Letter ↗AP
2003-05-13Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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