APPLICATION
ANDA078011
TYPE
ANDA
ORIGINAL APPROVAL
2009-07-22
LATEST ACTION
2020-07-27
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
VINORELBINE TARTRATEPrescription
VINORELBINE TARTRATE EQ 10MG BASE/ML · INJECTABLE · INJECTION
Approval history
2020-07-27Labeling · Supplement 6 · standardAP
2020-07-27Labeling · Supplement 4 · standardAP
2015-10-26Labeling · Supplement 3 · standardAP
2010-05-26Labeling · Supplement 1AP
2009-07-22OriginalAP
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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