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FDA ANDA · ANDA201191

TOPOTECAN HYDROCHLORIDE

Sponsor: DR REDDYS LABS LTD

APPLICATION
ANDA201191
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-09
LATEST ACTION
2015-12-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TOPOTECAN HYDROCHLORIDEPrescription
TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2015-12-11Labeling · Supplement 3 · standardAP
2015-12-11Labeling · Supplement 2 · standardAP
2011-03-09OriginalAP
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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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