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 INJECTABLE;INTRAVENOUS Prescription AP 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

BONIVA

INJECTABLE;INTRAVENOUS; EQ 3MG BASE/3ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BONIVA IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription Yes AP 021858 ROCHE
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 206058 ACCORD HLTHCARE
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 204222 APOTEX
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 205332 AUROBINDO PHARMA LTD
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 202671 MYLAN LABS LTD
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 202235 SAGENT PHARMS INC
IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE;INTRAVENOUS Prescription No AP 090853 SUN PHARM

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