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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021858
Company: ROCHE

Medication Guide

Other Important Information from FDA

Products on NDA 021858

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BONIVA	IBANDRONATE SODIUM	EQ 3MG BASE/3ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021858

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/06/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021858s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021858s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2022	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021858Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021858Orig1s023ltr.pdf
12/07/2016	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021858Orig1s022ltr.pdf
07/22/2015	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
04/08/2015	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021858Orig1s020ltr.pdf
03/18/2015	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021858Orig1s019ltr.pdf
05/04/2015	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
09/08/2014	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/20/2014	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/18/2014	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/19/2013	SUPPL-14	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf
04/19/2013	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf
07/01/2011	SUPPL-12	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s012ltr.pdf
08/10/2011	SUPPL-10	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s010ltr.pdf
01/25/2011	SUPPL-9	REMS-Proposal	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021858s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s009ltr.pdf
04/19/2013	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf
02/12/2007	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021858s004ltr.pdf
08/07/2006	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021858s001LTR.pdf

Labels for NDA 021858

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/11/2022	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021858Orig1s023lbl.pdf
12/07/2016	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf
04/08/2015	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s020lbl.pdf
03/18/2015	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s019lbl.pdf
04/19/2013	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf
04/19/2013	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf
04/19/2013	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf
01/25/2011	SUPPL-9	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021858s009lbl.pdf
08/07/2006	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s001lbl.pdf
01/06/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s000lbl.pdf

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