APPLICATION
ANDA207562
TYPE
ANDA
ORIGINAL APPROVAL
2018-10-16
LATEST ACTION
2025-10-22
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
OXALIPLATINDiscontinued
OXALIPLATIN 100MG/20ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATINDiscontinued
OXALIPLATIN 50MG/10ML (5MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2025-10-22Labeling · Supplement 10 · standardAP
2022-03-31Labeling · Supplement 6 · standardAP
2018-10-16UNKNOWN · 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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