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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021825
Company: CHIESI

Medication Guide

Summary Review

Products on NDA 021825

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FERRIPROX	DEFERIPRONE	500MG	TABLET;ORAL	Prescription	AB	Yes	No
FERRIPROX	DEFERIPRONE	1GM	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021825

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/14/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021825lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021825Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021825Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021825Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2021	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021825s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021825Orig1s010ltr.pdf
04/30/2021	SUPPL-8	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021825s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021825Orig1s008ltr.pdf
02/20/2020	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021825s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021825Orig1s007ltr.pdf
07/25/2019	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021825s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021825Orig1s004ltr.pdf
02/24/2015	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021825s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021825Orig1s003ltr.pdf
11/15/2012	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/20/2012	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021825s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021825s001ltr.pdf

Labels for NDA 021825

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2021	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021825s010lbl.pdf
11/30/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021825s010lbl.pdf
04/30/2021	SUPPL-8	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021825s008lbl.pdf
02/20/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021825s007lbl.pdf
02/20/2020	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021825s007lbl.pdf
07/25/2019	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021825s004lbl.pdf
02/24/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021825s003lbl.pdf
02/24/2015	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021825s003lbl.pdf
04/20/2012	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021825s001lbl.pdf
10/14/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021825lbl.pdf

Therapeutic Equivalents for NDA 021825

FERRIPROX

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERIPRONE	DEFERIPRONE	500MG	TABLET;ORAL	Prescription	No	AB	213239	HIKMA
DEFERIPRONE	DEFERIPRONE	500MG	TABLET;ORAL	Prescription	No	AB	208800	TARO
FERRIPROX	DEFERIPRONE	500MG	TABLET;ORAL	Prescription	Yes	AB	021825	CHIESI

TABLET;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERIPRONE	DEFERIPRONE	1GM	TABLET;ORAL	Prescription	No	AB	213239	HIKMA
DEFERIPRONE	DEFERIPRONE	1GM	TABLET;ORAL	Prescription	No	AB	208800	TARO
FERRIPROX	DEFERIPRONE	1GM	TABLET;ORAL	Prescription	Yes	AB	021825	CHIESI

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