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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021135
Company: AM REGENT

Products on NDA 21135

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VENOFER	IRON SUCROSE	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE;INTRAVENOUS	Prescription	AB	Yes	Yes
VENOFER	IRON SUCROSE	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE;INTRAVENOUS	Prescription	AB	Yes	No
VENOFER	IRON SUCROSE	EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML)	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No
VENOFER	IRON SUCROSE	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE;INTRAVENOUS	Prescription	AB	Yes	No
VENOFER	IRON SUCROSE	EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)	INJECTABLE;INTRAVENOUS	Discontinued	None	No	No

Labels for NDA 021135

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/02/2026	SUPPL-42	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021135Orig1s042lbl.pdf
08/01/2024	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021135s038lbl.pdf
01/20/2021	SUPPL-37	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021135Orig1s037lbl.pdf
01/20/2021	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021135Orig1s037lbl.pdf
09/11/2020	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021135s036lbl.pdf
12/19/2018	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021135s035lbl.pdf
11/28/2017	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021135s032lbl.pdf
11/28/2017	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021135s032lbl.pdf
03/29/2013	SUPPL-23	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021135s023lbl.pdf
09/21/2012	SUPPL-24	Efficacy-Pediatric	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021135s024lbl.pdf
06/22/2011	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021135s020lbl.pdf
12/03/2007	SUPPL-17	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s017lbl.pdf
02/09/2007	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf
02/09/2007	SUPPL-15	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021135s015lbl.pdf
10/17/2005	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s013lbl.pdf
06/17/2005	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021135s008lbl.pdf
07/26/2002	SUPPL-5	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21135se2-005ltr.pdf
11/06/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21135lbl.pdf

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