Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021468
Company: SHIRE LLC
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 SHIRE LLC
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 SHIRE LLC
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 SHIRE LLC
LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE;ORAL Prescription No AB 090978 NATCO PHARMA LTD

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