APPLICATION
ANDA207474
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-21
LATEST ACTION
2026-03-17
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
OXALIPLATINPrescription
OXALIPLATIN 100MG/20ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATINDiscontinued
OXALIPLATIN 200MG/40ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATINPrescription
OXALIPLATIN 50MG/10ML (5MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2026-03-17Labeling · Supplement 5 · standardAP
2026-03-17Labeling · Supplement 6 · standardAP
2022-02-08Labeling · Supplement 2 · standardAP
2017-03-21UNKNOWN · Original · standardAP
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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