APPLICATION
ANDA205529
TYPE
ANDA
ORIGINAL APPROVAL
2017-09-06
LATEST ACTION
2024-08-27
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
2024-08-27Labeling · Supplement 4 · standardAP
2022-01-13Labeling · Supplement 3 · standardAP
2017-09-06UNKNOWN · 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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