FDA NDA · NDA022453

TOPOTECAN HYDROCHLORIDE

Sponsor: MEITHEAL

APPLICATION

NDA022453

TYPE

NDA

ORIGINAL APPROVAL

2012-12-20

LATEST ACTION

2019-06-24

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

TOPOTECAN HYDROCHLORIDEDiscontinued

TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) · SOLUTION · INTRAVENOUS

2019-06-24Labeling · Supplement 11 · standard — Letter ↗AP

2017-09-20Efficacy · Supplement 10 · standard — Label ↗AP

2016-11-14Manufacturing (CMC) · Supplement 9 · standardAP

2016-01-29Labeling · Supplement 7 · standard — Label ↗AP

2015-12-21Manufacturing (CMC) · Supplement 8 · standardAP

2015-03-30Manufacturing (CMC) · Supplement 6 · standardAP

2015-02-23Manufacturing (CMC) · Supplement 4 · standardAP

2014-09-23Manufacturing (CMC) · Supplement 3 · standardAP

2014-02-28Labeling · Supplement 2 · standard — Letter ↗AP

2013-10-03Manufacturing (CMC) · Supplement 1 · standardAP

2012-12-20Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP

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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