APPLICATION
ANDA204368
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-07
LATEST ACTION
2023-12-11
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OXALIPLATINPrescription
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 16 · standardAP
2021-11-17Labeling · Supplement 3 · standardAP
2021-11-17Labeling · Supplement 5 · standardAP
2016-06-07UNKNOWN · 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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