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FDA NDA · NDA020671

HYCAMTIN

topotecan hydrochloride

Sponsor: SANDOZ

APPLICATION
NDA020671
TYPE
NDA
ORIGINAL APPROVAL
1996-05-28
LATEST ACTION
2019-10-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HYCAMTIN · ReferencePrescription
TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2019-10-08Labeling · Supplement 24 · standard — Letter ↗AP
2018-09-05Labeling · Supplement 23 · standard — Label ↗AP
2015-06-02Labeling · Supplement 21 · standard — Letter ↗AP
2014-02-28Labeling · Supplement 20 · standard — Label ↗AP
2010-03-26Labeling · Supplement 16 · standard — Letter ↗AP
2010-03-26Labeling · Supplement 17 · standard — Label ↗AP
2006-06-14Efficacy · Supplement 14 · priority — Label ↗AP
2003-05-09Labeling · Supplement 12 · standard — Letter ↗AP
2003-03-11Labeling · Supplement 11 · standard — Letter ↗AP
2003-02-26Efficacy · Supplement 10 · priority — Other ↗AP
2002-03-06Labeling · Supplement 9 · standard — Letter ↗AP
2001-08-03Manufacturing (CMC) · Supplement 8 · priorityAP
2000-02-10Manufacturing (CMC) · Supplement 7 · priorityAP
2000-01-18Manufacturing (CMC) · Supplement 6 · priorityAP
1998-11-30Efficacy · Supplement 4 · standard — Label ↗AP
1998-02-04Manufacturing (CMC) · Supplement 3 · priorityAP
1996-05-28Type 1 - New Molecular Entity · Original · priority — Review ↗AP
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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