APPLICATION
ANDA203869
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-18
LATEST ACTION
2024-01-05
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
2024-01-05Labeling · Supplement 10 · standardAP
2020-09-04Labeling · Supplement 6 · standardAP
2019-12-19Labeling · Supplement 1 · standardAP
2014-06-18UNKNOWN · 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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