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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021455
Company: HOFFMANN LA ROCHE

Medication Guide

Other Important Information from FDA

Products on NDA 021455

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BONIVA	IBANDRONATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
BONIVA	IBANDRONATE SODIUM	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021455

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/16/2003	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21455_boniva_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21455ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-455_Boniva.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/07/2016	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021455Orig1s021ltr.pdf
04/08/2015	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021455Orig1s020ltr.pdf
03/18/2015	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021455Orig1s019ltr.pdf
12/17/2014	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021455s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021455Orig1s018ltr.pdf
06/18/2014	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
04/05/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/19/2013	SUPPL-15	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021455Orig1s014,s015ltr.pdf
04/19/2013	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021455Orig1s014,s015ltr.pdf
07/01/2011	SUPPL-13	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021455s013ltr.pdf
01/25/2011	SUPPL-11	REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021455s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021455s011ltr.pdf
01/08/2010	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021455s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021455s009ltr.pdf
11/28/2008	SUPPL-7	Efficacy-New Indication	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021455s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021455Orig1s007.pdf
02/13/2007	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021455s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021455s005ltr.pdf
06/14/2006	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021455s003LTR.pdf
03/24/2005	SUPPL-1	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF) Patient Package Insert (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021455s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21455s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021455s001ppi.pdf

Labels for NDA 021455

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/07/2016	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf
04/08/2015	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf
03/18/2015	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s019lbl.pdf
12/17/2014	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021455s18lbl.pdf
04/19/2013	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf
04/19/2013	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf
04/19/2013	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf
01/25/2011	SUPPL-11	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021455s011lbl.pdf
01/08/2010	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021455s009lbl.pdf
02/13/2007	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021455s005lbl.pdf
03/24/2005	SUPPL-1	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021455s001lbl.pdf
05/16/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21455_boniva_lbl.pdf

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