← FDA DRUG APPROVALS

FDA NDA · NDA021227

CANCIDAS

caspofungin acetate

Sponsor: MERCK

APPLICATION
NDA021227
TYPE
NDA
ORIGINAL APPROVAL
2001-01-26
LATEST ACTION
2021-10-25
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

CANCIDAS · ReferenceDiscontinued
CASPOFUNGIN ACETATE 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAVENOUS
CANCIDAS · ReferenceDiscontinued
CASPOFUNGIN ACETATE 70MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAVENOUS

Approval history

2021-10-25Labeling · Supplement 40 · standard — Letter ↗AP
2019-02-08Labeling · Supplement 39 · standard — Label ↗AP
2018-03-13Labeling · Supplement 38 · standard — Label ↗AP
2017-08-25Labeling · Supplement 37 · standard — Label ↗AP
2017-08-09Labeling · Supplement 36 · standard — Label ↗AP
2016-04-12Labeling · Supplement 35 · standard — Letter ↗AP
2016-04-12Labeling · Supplement 34 · standard — Letter ↗AP
2014-10-23Labeling · Supplement 33 · standard — Label ↗AP
2013-12-18Manufacturing (CMC) · Supplement 32 · priorityAP
2013-08-02Labeling · Supplement 30 · standard — Letter ↗AP
2013-01-08Labeling · Supplement 31 · standard — Letter ↗AP
2012-04-30Labeling · Supplement 29 · standard — Letter ↗AP
2010-10-22Labeling · Supplement 28 · unknown — Letter ↗AP
2010-01-28Labeling · Supplement 27 · unknown — Letter ↗AP
2009-06-26Efficacy · Supplement 23 · unknown — Label ↗AP
2009-05-04Labeling · Supplement 24 · standard — Letter ↗AP
2008-07-29Efficacy · Supplement 21 · priority — Letter ↗AP
2008-07-21Labeling · Supplement 22 · standard — Letter ↗AP
2005-02-16Efficacy · Supplement 15 · unknown — Letter ↗AP
2004-09-29Efficacy · Supplement 12 · unknown — Letter ↗AP
2004-03-17Labeling · Supplement 11 · standard — Letter ↗AP
2004-03-17Labeling · Supplement 14 · standard — Letter ↗AP
2003-01-07Efficacy · Supplement 7 · standard — Letter ↗AP
2002-12-10Manufacturing (CMC) · Supplement 9 · priorityAP
2002-11-21Labeling · Supplement 5 · standard — Letter ↗AP
2002-11-15Manufacturing (CMC) · Supplement 8 · priorityAP
2002-09-20Labeling · Supplement 3 · standard — Letter ↗AP
2002-09-20Efficacy · Supplement 1 · standard — Letter ↗AP
2002-06-12Manufacturing (CMC) · Supplement 6 · priorityAP
2002-04-11Manufacturing (CMC) · Supplement 4 · priorityAP
2001-01-26Type 1 - New Molecular Entity · Original · priority — Review ↗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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