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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021468
Company: TAKEDA PHARMS USA

Medication Guide

Products on NDA 021468

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOSRENOL	LANTHANUM CARBONATE	EQ 250MG BASE	TABLET, CHEWABLE;ORAL	Discontinued	None	No	No
FOSRENOL	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE;ORAL	Prescription	AB	Yes	No
FOSRENOL	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE;ORAL	Prescription	AB	Yes	No
FOSRENOL	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021468

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21468lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21468ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-468_Fosrenol.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2023	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021468s026,204734s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021468Orig1s026;204734Orig1s008ltr.pdf
12/12/2023	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021468s024,204734s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021468Orig1s024; 204734Orig1s006ltr.pdf
05/11/2020	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021468s023,204734s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021468Orig1s023, 204734Orig1s005ltr.pdf
11/08/2018	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021468Orig1s021,204734Orig1s003ltr.pdf
02/24/2016	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021468Orig1s020,204734Orig1s001ltr.pdf
09/24/2014	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021468s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021468Orig1s019ltr.pdf
10/31/2012	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021468s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021468Orig1s018ltr.pdf
09/02/2011	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021468s016ltr.pdf
04/27/2011	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021468s014,s015ltr.pdf
04/27/2011	SUPPL-14	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021468s014,s015ltr.pdf
10/02/2008	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
10/23/2008	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021468s011ltr.pdf
04/10/2008	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021468s010ltr.pdf
03/03/2006	SUPPL-5	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021468s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021468_s005_fosrenol.pdf
03/03/2006	SUPPL-4	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021468_s004_fosrenol.pdf

Labels for NDA 021468

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2023	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021468s024,204734s006lbl.pdf
05/10/2023	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021468s026,204734s008lbl.pdf
05/11/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021468s023,204734s005lbl.pdf
11/08/2018	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf
02/24/2016	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.pdf
09/24/2014	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021468s019lbl.pdf
10/31/2012	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021468s018lbl.pdf
09/02/2011	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s016lbl.pdf
09/02/2011	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s016lbl.pdf
04/27/2011	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s014s015lbl.pdf
04/27/2011	SUPPL-14	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021468s014s015lbl.pdf
10/26/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21468lbl.pdf

Therapeutic Equivalents for NDA 021468

FOSRENOL

TABLET, CHEWABLE;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSRENOL	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	021468	TAKEDA PHARMS USA
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090977	BARR
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	206868	INVAGEN PHARMS
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090978	NATCO PHARMA LTD

TABLET, CHEWABLE;ORAL; EQ 750MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSRENOL	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	021468	TAKEDA PHARMS USA
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090977	BARR
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	206868	INVAGEN PHARMS
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090978	NATCO PHARMA LTD

TABLET, CHEWABLE;ORAL; EQ 1GM BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSRENOL	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	021468	TAKEDA PHARMS USA
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090977	BARR
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	206868	INVAGEN PHARMS
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090978	NATCO PHARMA LTD

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