APPLICATION
ANDA078803
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-08
LATEST ACTION
2023-11-29
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
OXALIPLATINDiscontinued
OXALIPLATIN 100MG/VIAL · INJECTABLE · INTRAVENOUS
OXALIPLATINDiscontinued
OXALIPLATIN 50MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2023-11-29Labeling · Supplement 7 · standardAP
2015-12-31Labeling · Supplement 3 · standardAP
2015-12-31Labeling · Supplement 4 · standardAP
2013-03-20Labeling · Supplement 2 · standardAP
2012-08-08UNKNOWN · OriginalAP
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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