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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076068
Company: HIKMA

Products on ANDA 076068

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No
DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076068

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76068ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/05/2017	SUPPL-15	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076068

DEXRAZOXANE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 250MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	200752	EUGIA PHARMA
DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207321	GLAND
DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 250MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076068	HIKMA

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	200752	EUGIA PHARMA
DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	207321	GLAND
DEXRAZOXANE HYDROCHLORIDE	DEXRAZOXANE HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076068	HIKMA

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