Details for New Drug Application (NDA): 022025

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NDA 022025 describes TOTECT, which is a drug marketed by Clinigen and is included in one NDA. Additional details are available on the TOTECT profile page.

The generic ingredient in TOTECT is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.

Summary for 022025

Tradename:	TOTECT
Applicant:	Clinigen
Ingredient:	dexrazoxane hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 022025

Antineoplastic Agents
Cardiotonic Agents
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 6, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 022025

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clinigen	TOTECT	dexrazoxane hydrochloride	INJECTABLE;INJECTION	022025-001	Sep 6, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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