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FDA ANDA · ANDA202922

OXALIPLATIN

Sponsor: SUN PHARM

APPLICATION
ANDA202922
TYPE
ANDA
ORIGINAL APPROVAL
2014-04-08
LATEST ACTION
2019-02-15
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

OXALIPLATINDiscontinued
OXALIPLATIN 200MG/40ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATINDiscontinued
OXALIPLATIN 50MG/10ML (5MG/ML) · INJECTABLE · INTRAVENOUS
OXALIPLATINDiscontinued
OXALIPLATIN 100MG/20ML (5MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2019-02-15UNKNOWN · OriginalAP
2016-05-26Labeling · Supplement 1 · standardAP
2014-04-08UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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