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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203565
Company: AM REGENT

Summary Review

Products on NDA 203565

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203565

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.

Labels for NDA 203565

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

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