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FDA NDA · NDA200199

TOPOTECAN

Sponsor: SANDOZ INC

APPLICATION
NDA200199
TYPE
NDA
ORIGINAL APPROVAL
2011-02-25
LATEST ACTION
2014-02-28
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

TOPOTECAN · ReferenceDiscontinued
TOPOTECAN HYDROCHLORIDE EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
TOPOTECAN · ReferenceDiscontinued
TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
TOPOTECAN · ReferenceDiscontinued
TOPOTECAN HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2014-02-28Labeling · Supplement 3 · standard — Label ↗AP
2011-02-25Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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