APPLICATION
ANDA091089
TYPE
ANDA
ORIGINAL APPROVAL
2010-11-29
LATEST ACTION
2020-08-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TOPOTECAN HYDROCHLORIDEPrescription
TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2020-08-20Labeling · Supplement 6 · standardAP
2016-02-26Labeling · Supplement 4 · standardAP
2016-02-26Labeling · Supplement 2 · standardAP
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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