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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208030
Company: CHIESI

Medication Guide

Summary Review

Products on NDA 208030

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FERRIPROX	DEFERIPRONE	100MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes
FERRIPROX	DEFERIPRONE	80MG/ML	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208030

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208030Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208030Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208030Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2021	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208030s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208030Orig1s007ltr.pdf
04/30/2021	SUPPL-5	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208030s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208030Orig1s005ltr.pdf
02/20/2020	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208030s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208030Orig1s004ltr.pdf
04/20/2018	SUPPL-2	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208030s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208030Orig1s002ltr.pdf

Labels for NDA 208030

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/30/2021	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208030s007lbl.pdf
11/30/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208030s007lbl.pdf
04/30/2021	SUPPL-5	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208030s005lbl.pdf
02/20/2020	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208030s004lbl.pdf
02/20/2020	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208030s004lbl.pdf
04/20/2018	SUPPL-2	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208030s002lbl.pdf
09/09/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208030lbl.pdf

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