APPLICATION
ANDA207325
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-10
LATEST ACTION
2023-12-11
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
OXALIPLATINDiscontinued
OXALIPLATIN 200MG/40ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATINPrescription
OXALIPLATIN 50MG/10ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATINPrescription
OXALIPLATIN 100MG/20ML (5MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2023-12-11Labeling · Supplement 9 · standardAP
2021-12-15Labeling · Supplement 4 · standardAP
2017-02-10UNKNOWN · 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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