APPLICATION
ANDA078811
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-10
LATEST ACTION
2024-08-27
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OXALIPLATINPrescription
OXALIPLATIN 50MG/10ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATINPrescription
OXALIPLATIN 100MG/20ML (5MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2024-08-27Labeling · Supplement 27 · standardAP
2021-11-18Labeling · Supplement 19 · standardAP
2019-12-18Labeling · Supplement 14 · standardAP
2015-05-04Labeling · Supplement 2 · standardAP
2015-05-04Labeling · Supplement 10 · standardAP
2014-05-13Manufacturing (CMC) · Supplement 1AP
2013-09-05Labeling · Supplement 5 · standardAP
2010-06-10OriginalAP
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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