APPLICATION
ANDA091542
TYPE
ANDA
ORIGINAL APPROVAL
2012-08-28
LATEST ACTION
2021-03-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TOPOTECAN HYDROCHLORIDEDiscontinued
TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-03-19Manufacturing (CMC) · Supplement 7 · standardAP
2021-03-19Labeling · Supplement 6 · standardAP
2015-12-03Labeling · Supplement 1 · standardAP
2015-12-03Labeling · Supplement 4 · standardAP
2012-08-28OriginalAP
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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