APPLICATION
ANDA206962
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-30
LATEST ACTION
2024-02-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TOPOTECAN HYDROCHLORIDEPrescription
TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-02-23Labeling · Supplement 1 · standardAP
2016-11-30UNKNOWN · Original · 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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