Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021825
Company: CHIESI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FERRIPROX DEFERIPRONE 500MG TABLET;ORAL Prescription AB Yes Yes
FERRIPROX DEFERIPRONE 1GM TABLET;ORAL Prescription None Yes No
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
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-Medication Guide, Labeling-Package Insert 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021825s003lbl.pdf
02/24/2015 SUPPL-3 Labeling-Package Insert 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

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 PHARMS
DEFERIPRONE DEFERIPRONE 500MG TABLET;ORAL Prescription No AB 208800 TARO PHARM INDS LTD
FERRIPROX DEFERIPRONE 500MG TABLET;ORAL Prescription Yes AB 021825 CHIESI

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