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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204734
Company: TAKEDA PHARMS USA

Medication Guide

Summary Review

Products on NDA 204734

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOSRENOL	LANTHANUM CARBONATE	EQ 750MG BASE	POWDER;ORAL	Prescription	None	Yes	No
FOSRENOL	LANTHANUM CARBONATE	EQ 1GM BASE	POWDER;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204734

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2014	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204734Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204734Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2023	SUPPL-8	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-6	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-5	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-3	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-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204734s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204734Orig1s000ltr.pdf

Labels for NDA 204734

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021468s024,204734s006lbl.pdf
05/10/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021468s026,204734s008lbl.pdf
05/11/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021468s023,204734s005lbl.pdf
11/08/2018	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021468s021,204734s003lbl.pdf
02/24/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204734s000lbl.pdf
09/24/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021468s020,204734s001lbl.pdf

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