← FDA DRUG APPROVALS

FDA NDA · NDA021660

ABRAXANE

paclitaxel

Sponsor: BRISTOL-MYERS

APPLICATION
NDA021660
TYPE
NDA
ORIGINAL APPROVAL
2005-01-07
LATEST ACTION
2020-08-25
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ABRAXANE · ReferencePrescription
PACLITAXEL 100MG/VIAL · POWDER · INTRAVENOUS

Approval history

2020-08-25Labeling · Supplement 47 · standard — Letter ↗AP
2019-12-06Efficacy · Supplement 46 · priority — Label ↗AP
2018-08-16Labeling · Supplement 45 · standard — Label ↗AP
2016-03-24Manufacturing (CMC) · Supplement 43 · standardAP
2015-11-02Manufacturing (CMC) · Supplement 42 · standardAP
2015-07-21Labeling · Supplement 41 · standard — Label ↗AP
2014-12-11Labeling · Supplement 40 · standard — Letter ↗AP
2014-04-28Manufacturing (CMC) · Supplement 39 · standardAP
2013-10-30Labeling · Supplement 38 · standard — Label ↗AP
2013-09-06Efficacy · Supplement 37 · priority — Label ↗AP
2013-06-07Labeling · Supplement 36 · standard — Label ↗AP
2012-12-10Manufacturing (CMC) · Supplement 33 · standardAP
2012-10-11Efficacy · Supplement 31 · standard — Label ↗AP
2012-09-28Labeling · Supplement 34 · standard — Label ↗AP
2012-09-28Labeling · Supplement 35 · standard — Label ↗AP
2011-12-23Labeling · Supplement 25 · unknown — Label ↗AP
2011-12-23Labeling · Supplement 26 · unknown — Label ↗AP
2011-12-23Labeling · Supplement 29 · unknown — Review ↗AP
2009-06-26Labeling · Supplement 22 · standard — Label ↗AP
2008-07-01Labeling · Supplement 13 · standard — Label ↗AP
2007-02-15Efficacy · Supplement 10 · unknown — Label ↗AP
2005-01-07Type 5 - New Formulation or New Manufacturer · Original · standard — 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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