APPLICATION
ANDA078812
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-07
LATEST ACTION
2015-09-10
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
OXALIPLATINDiscontinued
OXALIPLATIN 50MG/10ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATINDiscontinued
OXALIPLATIN 100MG/20ML (5MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2015-09-10Labeling · Supplement 6 · standardAP
2015-09-10Labeling · Supplement 3 · standardAP
2013-02-28Labeling · Supplement 2 · standardAP
2009-08-07OriginalAP
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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