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FDA NDA · NDA021759

OXALIPLATIN

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA021759
TYPE
NDA
ORIGINAL APPROVAL
2005-01-31
LATEST ACTION
2023-06-23
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ELOXATIN · ReferenceDiscontinued
OXALIPLATIN 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS
ELOXATIN · ReferenceDiscontinued
OXALIPLATIN 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS
ELOXATIN · ReferenceDiscontinued
OXALIPLATIN 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INTRAVENOUS

Approval history

2023-06-23Labeling · Supplement 24 · standard — Letter ↗AP
2020-04-06Labeling · Supplement 23 · standard — Letter ↗AP
2016-12-09Manufacturing (CMC) · Supplement 21 · standardAP
2015-10-01Labeling · Supplement 19 · standard — Letter ↗AP
2015-01-20Manufacturing (CMC) · Supplement 18 · standardAP
2013-11-15Manufacturing (CMC) · Supplement 17 · standardAP
2013-07-16Labeling · Supplement 16 · standard — Letter ↗AP
2012-10-12Labeling · Supplement 15 · standard — Label ↗AP
2011-12-28Labeling · Supplement 12 · unknown — Label ↗AP
2009-07-22Manufacturing (CMC) · Supplement 10AP
2009-03-13Labeling · Supplement 9 · standard — Label ↗AP
2008-05-21Labeling · Supplement 8 · standard — Letter ↗AP
2006-11-17Manufacturing (CMC) · Supplement 6AP
2006-03-09Labeling · Supplement 1 · standard — Letter ↗AP
2005-01-31Type 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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