APPLICATION
ANDA090620
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-02
LATEST ACTION
2020-01-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TOPOTECAN HYDROCHLORIDEPrescription
TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2020-01-13Labeling · Supplement 8 · standardAP
2020-01-13Labeling · Supplement 9 · standardAP
2015-09-28Labeling · Supplement 6 · standardAP
2015-09-28Labeling · Supplement 7 · standardAP
2015-09-28Labeling · Supplement 5 · standardAP
2013-04-30Labeling · Supplement 4AP
2011-02-08Labeling · Supplement 1AP
2010-12-02OriginalAP
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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