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FDA NDA · NDA022025

TOTECT

Sponsor: CLINIGEN

APPLICATION
NDA022025
TYPE
NDA
ORIGINAL APPROVAL
2007-09-06
LATEST ACTION
2022-04-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TOTECT · ReferenceDiscontinued
DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2022-04-29Labeling · Supplement 20 · standardAP
2020-11-02Efficacy · Supplement 19 · standard — Letter ↗AP
2018-11-16Labeling · Supplement 18 · standard — Label ↗AP
2018-02-08Labeling · Supplement 16 · standard — Label ↗AP
2017-06-19Manufacturing (CMC) · Supplement 15 — Label ↗AP
2013-04-26Labeling · Supplement 13 · standard — Label ↗AP
2013-02-12Manufacturing (CMC) · Supplement 14 · priorityAP
2011-03-07Labeling · Supplement 11 · unknown — Letter ↗AP
2009-09-16Labeling · Supplement 5 · standard — Label ↗AP
2009-02-11Labeling · Supplement 1 · standard — Label ↗AP
2007-09-06Type 5 - New Formulation or New Manufacturer · Original · priority — Review ↗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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