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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 AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2021 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021825s010lbl.pdf
11/30/2021 SUPPL-10 Labeling-Medication Guide 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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021825s007lbl.pdf
02/20/2020 SUPPL-7 Labeling-Package Insert 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
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