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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020955
Company: SANOFI AVENTIS US

Products on NDA 020955

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FERRLECIT	FERRIC OXYHYDROXIDE	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE;INJECTION	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020955

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/18/1999	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20955lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20955ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20955_Ferrlecit.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2022	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020955s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020955Orig1s020ltr.pdf
12/02/2020	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020955s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020955Orig1s019ltr.pdf
03/31/2020	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020955s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020955Orig1s017ltr.pdf
02/01/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/25/2011	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020955s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020955Orig1s013,s015ltr.pdf
08/25/2011	SUPPL-13	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020955s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020955Orig1s013,s015ltr.pdf
10/02/2006	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020955s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020955s010LTR.pdf
08/13/2004	SUPPL-6	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20955s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20955s006ltr.pdf
06/07/2002	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20955s005ltr.pdf
04/09/2002	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/02/2001	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20955s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20955s3ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020955_S003_FERRLECIT_AP.pdf
07/27/1999	SUPPL-1	Manufacturing (CMC)-Expiration Date	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020955_S001_FERRLECIT_AP.pdf

Labels for NDA 020955

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/16/2022	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020955s020lbl.pdf
12/02/2020	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020955s019lbl.pdf
03/31/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020955s017lbl.pdf
08/25/2011	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020955s013s015lbl.pdf
08/25/2011	SUPPL-13	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020955s013s015lbl.pdf
10/02/2006	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020955s010lbl.pdf
08/13/2004	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20955s006lbl.pdf
02/02/2001	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20955s3lbl.pdf
02/18/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20955lbl.pdf

Therapeutic Equivalents for NDA 020955

FERRLECIT

INJECTABLE;INJECTION; EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FERRLECIT	FERRIC OXYHYDROXIDE	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE;INJECTION	Prescription	Yes	AB	020955	SANOFI AVENTIS US
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE	FERRIC OXYHYDROXIDE	EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)	INJECTABLE;INJECTION	Prescription	No	AB	078215	WEST-WARD PHARMS INT

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