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FDA NDA · NDA022160

OXALIPLATIN

Sponsor: TEVA PHARMS

APPLICATION
NDA022160
TYPE
NDA
ORIGINAL APPROVAL
2009-08-07
LATEST ACTION
2024-10-31
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

OXALIPLATIN · ReferenceDiscontinued
OXALIPLATIN 100MG/20ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATIN · ReferenceDiscontinued
OXALIPLATIN 50MG/10ML (5MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2024-10-31Labeling · Supplement 16 · standard — Label ↗AP
2020-04-10Labeling · Supplement 12 · standard — Label ↗AP
2016-04-20Labeling · Supplement 10 · standard — Label ↗AP
2013-11-25Labeling · Supplement 9 · standard — Label ↗AP
2013-11-25Labeling · Supplement 8 · standard — Letter ↗AP
2012-11-20Manufacturing (CMC) · Supplement 5 · standardAP
2012-08-10Labeling · Supplement 4 · standard — Label ↗AP
2009-08-07Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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