Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203565
Company: AM REGENT
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 |
INJECTAFER | FERRIC CARBOXYMALTOSE | 1GM IRON/20ML (50MG IRON/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
INJECTAFER | FERRIC CARBOXYMALTOSE | 100MG IRON/2ML (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 |
---|---|---|---|---|---|
05/31/2023 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Supplement 20 was approved after Supplement 24 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203565s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203565Orig1s024ltr.pdf |
05/31/2023 | SUPPL-20 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
Supplement 20 was approved after Supplement 24 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203565s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203565Orig1s020ltr.pdf |
02/04/2022 | SUPPL-19 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203565Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203565Orig1s019ltr.pdf | ||
08/04/2021 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203565Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203565Orig1s017ltr.pdf | |
11/19/2021 | SUPPL-16 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203565Orig1s016_CORRECTED_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203565Orig1s016_CORRECTED_ltr.pdf | |
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 |
---|---|---|---|---|---|
05/31/2023 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | Supplement 20 was approved after Supplement 24 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203565s024lbl.pdf |
05/31/2023 | SUPPL-20 | Efficacy-New Indication | Label (PDF) | Supplement 20 was approved after Supplement 24 | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203565s020lbl.pdf |
02/04/2022 | SUPPL-19 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203565Orig1s019lbl.pdf | |
11/19/2021 | SUPPL-16 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203565Orig1s016_CORRECTED_lbl.pdf | |
08/04/2021 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203565Orig1s017lbl.pdf | |
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 |