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FDA NDA · NDA021673

CLOLAR

Sponsor: GENZYME

APPLICATION
NDA021673
TYPE
NDA
ORIGINAL APPROVAL
2004-12-28
LATEST ACTION
2022-07-18
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

CLOLAR · ReferenceDiscontinued
CLOFARABINE 20MG/20ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2022-07-18Efficacy · Supplement 27 · standard — Letter ↗AP
2019-12-20Labeling · Supplement 26 · standard — Label ↗AP
2016-10-27Labeling · Supplement 25 · standard — Letter ↗AP
2015-12-16Labeling · Supplement 24 · standard — Letter ↗AP
2014-09-15Labeling · Supplement 23 · standard — Letter ↗AP
2013-01-10Labeling · Supplement 22 · standard — Label ↗AP
2011-06-10Labeling · Supplement 10 · standard — Label ↗AP
2008-10-17Labeling · Supplement 7 · standard — Letter ↗AP
2008-10-17Efficacy · Supplement 5 · unknown — Letter ↗AP
2004-12-28Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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