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FDA NDA · NDA021572

CUBICIN

Sponsor: CUBIST PHARMS LLC

APPLICATION
NDA021572
TYPE
NDA
ORIGINAL APPROVAL
2003-09-12
LATEST ACTION
2025-05-12
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

CUBICIN · ReferenceDiscontinued
DAPTOMYCIN 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAVENOUS
CUBICIN RF · ReferenceDiscontinued
DAPTOMYCIN 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAVENOUS
CUBICINDiscontinued
DAPTOMYCIN 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAVENOUS

Approval history

2025-05-12Labeling · Supplement 70 · standard — Letter ↗AP
2025-05-08Labeling · Supplement 69 · standard — Letter ↗AP
2022-02-23Labeling · Supplement 68 · standard — Letter ↗AP
2021-10-26Labeling · Supplement 65 · standard — Letter ↗AP
2021-10-26Labeling · Supplement 66 · standard — Letter ↗AP
2020-08-26Labeling · Supplement 63 · standard — Letter ↗AP
2020-08-26Labeling · Supplement 64 · standard — Letter ↗AP
2018-12-03Labeling · Supplement 61 · standard — Label ↗AP
2017-09-01Efficacy · Supplement 57 · priority — Label ↗AP
2017-09-01Labeling · Supplement 60 · standard — Label ↗AP
2017-06-09Labeling · Supplement 59 · standard — Label ↗AP
2017-03-29Efficacy · Supplement 55 · priority — Label ↗AP
2017-03-29Labeling · Supplement 58 · standard — Label ↗AP
2016-07-07Labeling · Supplement 53 · standard — Label ↗AP
2016-07-06Labeling · Supplement 52 · priority — Review ↗AP
2016-03-15Labeling · Supplement 51 · standardAP
2015-09-17Labeling · Supplement 50 · standard — Letter ↗AP
2015-08-03Labeling · Supplement 48 · standard — Letter ↗AP
2015-07-15Manufacturing (CMC) · Supplement 49 · priorityAP
2015-02-16Manufacturing (CMC) · Supplement 47 · priorityAP
2014-11-26Labeling · Supplement 46 · standard — Letter ↗AP
2014-09-26Manufacturing (CMC) · Supplement 45 · priorityAP
2013-11-22Labeling · Supplement 43 · standard — Label ↗AP
2013-11-22Labeling · Supplement 44 · standard — Label ↗AP
2013-06-26Manufacturing (CMC) · Supplement 42 · priorityAP
2013-03-19Manufacturing (CMC) · Supplement 41 · priorityAP
2012-10-11Labeling · Supplement 40 · standard — Letter ↗AP
2012-06-14Labeling · Supplement 39 · unknown — Label ↗AP
2012-05-22Labeling · Supplement 37 · unknown — Label ↗AP
2011-10-03Labeling · Supplement 38 · unknown — Letter ↗AP
2010-12-14Manufacturing (CMC) · Supplement 34 · priorityAP
2010-12-06Labeling · Supplement 31 · unknown — Letter ↗AP
2010-11-30Labeling · Supplement 32 · unknown — Label ↗AP
2010-11-30Labeling · Supplement 24 · standard — Label ↗AP
2010-11-30Labeling · Supplement 30 · unknown — Label ↗AP
2010-11-30Labeling · Supplement 22 · standard — Letter ↗AP
2010-11-30Labeling · Supplement 27 · standard — Label ↗AP
2010-11-30Efficacy · Supplement 23 · unknown — Label ↗AP
2010-08-13Labeling · Supplement 33 · unknown — Label ↗AP
2009-02-10Labeling · Supplement 21 · standard — Letter ↗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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