APPLICATION
ANDA078817
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-24
LATEST ACTION
2023-11-28
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OXALIPLATINPrescription
OXALIPLATIN 100MG/20ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATINPrescription
OXALIPLATIN 50MG/10ML (5MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2023-11-28Labeling · Supplement 27 · standardAP
2021-11-18Labeling · Supplement 25 · standardAP
2015-12-11Labeling · Supplement 8 · standardAP
2015-12-11Labeling · Supplement 7 · standardAP
2015-12-11Labeling · Supplement 16 · standardAP
2013-02-27Labeling · Supplement 1AP
2011-01-24OriginalTA
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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