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Approved Drug Products containing Dexrazoxane listed in the FDA Orange Book. Original Data : FDA Website

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02 2EUGIA PHARMA

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04 2HIKMA

05 2PFIZER

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01

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

DEXRAZOXANE HYDROCHLORIDE

Brand Name : DEXRAZOXANE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 250MG BASE/VIAL

Approval Date : 2011-10-19

Application Number : 200752

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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02

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

DEXRAZOXANE HYDROCHLORIDE

Brand Name : DEXRAZOXANE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 500MG BASE/VIAL

Approval Date : 2011-10-19

Application Number : 200752

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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03

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

DEXRAZOXANE HYDROCHLORIDE

Brand Name : TOTECT

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2007-09-06

Application Number : 22025

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

DEXRAZOXANE HYDROCHLORIDE

Brand Name : DEXRAZOXANE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 500MG BASE/VIAL

Approval Date : 2016-11-28

Application Number : 207321

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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05

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

DEXRAZOXANE HYDROCHLORIDE

Brand Name : DEXRAZOXANE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 250MG BASE/VIAL

Approval Date : 2019-12-16

Application Number : 207321

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

DEXRAZOXANE HYDROCHLORIDE

Brand Name : DEXRAZOXANE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 250MG BASE/VIAL

Approval Date : 2004-09-28

Application Number : 76068

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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07

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

DEXRAZOXANE HYDROCHLORIDE

Brand Name : DEXRAZOXANE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 500MG BASE/VIAL

Approval Date : 2004-09-28

Application Number : 76068

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

DEXRAZOXANE HYDROCHLORIDE

Brand Name : ZINECARD

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 250MG BASE/VIAL

Approval Date : 1995-05-26

Application Number : 20212

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

DEXRAZOXANE HYDROCHLORIDE

Brand Name : ZINECARD

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 500MG BASE/VIAL

Approval Date : 1995-05-26

Application Number : 20212

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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