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FDA NDA · NDA021492

ELOXATIN

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA021492
TYPE
NDA
ORIGINAL APPROVAL
2002-08-09
LATEST ACTION
2020-04-06
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ELOXATIN · ReferenceDiscontinued
OXALIPLATIN 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS
ELOXATIN · ReferenceDiscontinued
OXALIPLATIN 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2020-04-06Labeling · Supplement 16 · standard — Letter ↗AP
2015-10-01Labeling · Supplement 14 · standard — Label ↗AP
2012-10-12Labeling · Supplement 13 · standard — Label ↗AP
2011-12-28Labeling · Supplement 12 · unknown — Label ↗AP
2009-03-13Labeling · Supplement 11 · standard — Letter ↗AP
2008-05-21Efficacy · Supplement 10 · standard — Letter ↗AP
2007-01-10Efficacy · Supplement 8 · priority — Pediatric Medical Review ↗AP
2006-03-09Labeling · Supplement 6 · standard — Label ↗AP
2004-11-04Labeling · Supplement 5 · standard — Label ↗AP
2004-11-04Efficacy · Supplement 4 · unknown — Letter ↗AP
2004-01-09Efficacy · Supplement 2 · priority — Letter ↗AP
2003-01-14Labeling · Supplement 1 · standard — Letter ↗AP
2002-08-09Type 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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