Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203565
Company: AM REGENT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INJECTAFER FERRIC CARBOXYMALTOSE 750MG IRON/15ML (50MG IRON/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
INJECTAFER FERRIC CARBOXYMALTOSE 500MG IRON/10ML (50MG IRON/ML) SOLUTION;INTRAVENOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/2013 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203565s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203565s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203565Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203565Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2021 SUPPL-14 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203565s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203565Orig1s014ltr.pdf
09/11/2020 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203565s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203565Orig1s013ltr.pdf
10/08/2020 SUPPL-12 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203565Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203565Orig1s012ltr.pdf
02/19/2020 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203565s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203565Orig1s009ltr.pdf
10/25/2018 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203565s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203565Orig1s008ltr.pdf
01/26/2018 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203565s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203565Orig1s005ltr.pdf
11/16/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/03/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/16/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/28/2021 SUPPL-14 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203565s014lbl.pdf
10/08/2020 SUPPL-12 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203565Orig1s012lbl.pdf
09/11/2020 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203565s013lbl.pdf
02/19/2020 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203565s009lbl.pdf
10/25/2018 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203565s008lbl.pdf
01/26/2018 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203565s005lbl.pdf
07/25/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203565s000lbl.pdf

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