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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021858
Company: ROCHE

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BONIVA IBANDRONATE SODIUM EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INTRAVENOUS Discontinued None Yes No

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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