← FDA DRUG APPROVALS

FDA NDA · NDA020981

HYCAMTIN

topotecan

Sponsor: SANDOZ

APPLICATION
NDA020981
TYPE
NDA
ORIGINAL APPROVAL
2007-10-11
LATEST ACTION
2018-09-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

HYCAMTIN · ReferencePrescription
TOPOTECAN HYDROCHLORIDE EQ 0.25MG BASE · CAPSULE · ORAL
HYCAMTIN · ReferencePrescription
TOPOTECAN HYDROCHLORIDE EQ 1MG BASE · CAPSULE · ORAL

Approval history

2018-09-05Labeling · Supplement 8 · standard — Label ↗AP
2014-06-18Labeling · Supplement 6 · standard — Letter ↗AP
2011-10-07Labeling · Supplement 5 · unknown — Letter ↗AP
2010-06-30Labeling · Supplement 2 · standard — Letter ↗AP
2008-09-05Manufacturing (CMC) · Supplement 1AP
2007-10-11Type 3 - New Dosage Form · Original · priority — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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