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FDA ANDA · ANDA202351

TOPOTECAN HYDROCHLORIDE

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA202351
TYPE
ANDA
ORIGINAL APPROVAL
2013-06-26
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 5 · standardAP
2015-11-17Labeling · Supplement 3 · standardAP
2015-11-17Labeling · Supplement 1 · standardAP
2013-06-26OriginalAP
VIEW ON DRUGS@FDA ↗

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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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