Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125320
Company: AMGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROLIA DENOSUMAB 60MG/ML INJECTABLE; SUBCUTANEOUS Prescription None No No
XGEVA DENOSUMAB 70MG/ML INJECTABLE; SUBCUTANEOUS Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/01/2010 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s0000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125320s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/30/2019 SUPPL-200 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s200lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125320Orig1s200ltr.pdf
05/08/2019 SUPPL-199 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s196s199lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125320Orig1s196,s199ltr.pdf
07/26/2019 SUPPL-198 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s198lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125320Orig1s198ltr.pdf
05/08/2019 SUPPL-196 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s196s199lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125320Orig1s196,s199ltr.pdf
05/24/2019 SUPPL-195 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s195lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125320Orig1s195ltr.pdf
06/07/2018 SUPPL-191 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s191lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125320Orig1s191ltr.pdf
05/18/2018 SUPPL-186 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s186lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125320Orig1s186ltr.pdf
01/24/2018 SUPPL-185 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s185lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125320Orig1s185ltr.pdf
01/04/2018 SUPPL-182 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s182lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125320s182ltr.pdf
05/26/2017 SUPPL-181 Supplement Label (PDF)
Letter (PDF)
Label for PROLIA https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125320s181lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125320Orig1s181ltr.pdf
01/31/2017 SUPPL-180 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125320Orig1s180ltr.pdf
08/05/2016 SUPPL-178 Supplement Label (PDF)
Letter (PDF)
Label for PROLIA https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320s178lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s178ltr.pdf
03/02/2016 SUPPL-177 Supplement Label (PDF)
Letter (PDF)
Label for XGEVA https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320Orig1s177lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125320Orig1s177ltr.pdf
04/08/2015 SUPPL-174 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s174lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s174ltr.pdf
02/26/2015 SUPPL-170 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s170lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s170ltr.pdf
06/08/2015 SUPPL-168 Supplement Label (PDF)
Letter (PDF)
Label for XGEVA https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s168lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s168ltr.pdf
05/21/2015 SUPPL-162 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125320Orig1s162ltr.pdf
12/05/2014 SUPPL-160 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s160lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125320Orig1s160ltr.pdf
06/04/2014 SUPPL-155 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s155lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125320Orig1s155ltr.pdf
06/16/2014 SUPPL-150 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s150lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125320Orig1s150ltr.pdf
08/23/2013 SUPPL-124 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s114s124lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s114, s124ltr.pdf
08/23/2013 SUPPL-114 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s114s124lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s114, s124ltr.pdf
07/03/2013 SUPPL-113 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s113lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s113ltr.pdf
06/13/2013 SUPPL-94 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s094ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125320Orig1s094.pdf
09/14/2012 SUPPL-85 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320Orig1s0085ltr.pdf
02/15/2013 SUPPL-80 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125320Orig1s080ltr.pdf
06/07/2012 SUPPL-78 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320s0078ltr.pdf
04/27/2012 SUPPL-54 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320s0054ltr.pdf
05/10/2012 SUPPL-53 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320s0053ltr.pdf
09/20/2012 SUPPL-51 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125320Orig1s0051ltr.pdf
07/22/2011 SUPPL-20 Supplement

Label is not available on this site.

11/18/2010 SUPPL-7 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125320s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/125320Orig1s007.pdf
09/16/2011 SUPPL-6 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125320s5s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125320s005,s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125320Orig1s006.pdf
09/16/2011 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125320s5s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125320s005,s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125320Orig1s005.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/26/2019 SUPPL-198 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s198lbl.pdf
07/26/2019 SUPPL-198 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s198lbl.pdf
05/24/2019 SUPPL-195 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s195lbl.pdf
05/08/2019 SUPPL-199 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s196s199lbl.pdf
05/08/2019 SUPPL-196 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s196s199lbl.pdf
04/30/2019 SUPPL-200 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s200lbl.pdf
04/30/2019 SUPPL-200 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s200lbl.pdf
04/30/2019 SUPPL-200 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s200lbl.pdf
06/07/2018 SUPPL-191 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s191lbl.pdf
05/18/2018 SUPPL-186 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s186lbl.pdf
01/24/2018 SUPPL-185 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s185lbl.pdf
01/04/2018 SUPPL-182 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s182lbl.pdf
05/26/2017 SUPPL-181 Efficacy-Labeling Change With Clinical Data Label (PDF) Label for PROLIA https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125320s181lbl.pdf
08/05/2016 SUPPL-178 Labeling-Package Insert Label (PDF) Label for PROLIA https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320s178lbl.pdf
03/02/2016 SUPPL-177 Labeling-Package Insert Label (PDF) Label for XGEVA https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125320Orig1s177lbl.pdf
06/08/2015 SUPPL-168 Labeling-Package Insert Label (PDF) Label for XGEVA https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s168lbl.pdf
04/08/2015 SUPPL-174 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s174lbl.pdf
02/26/2015 SUPPL-170 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125320s170lbl.pdf
12/05/2014 SUPPL-160 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s160lbl.pdf
06/16/2014 SUPPL-150 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s150lbl.pdf
06/04/2014 SUPPL-155 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125320s155lbl.pdf
08/23/2013 SUPPL-124 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s114s124lbl.pdf
08/23/2013 SUPPL-114 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s114s124lbl.pdf
07/03/2013 SUPPL-113 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s113lbl.pdf
06/13/2013 SUPPL-94 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s094lbl.pdf
02/15/2013 SUPPL-80 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125320s080lbl.pdf
09/20/2012 SUPPL-51 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0051lbl.pdf
09/14/2012 SUPPL-85 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0085lbl.pdf
06/07/2012 SUPPL-78 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0078lbl.pdf
05/10/2012 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0053lbl.pdf
04/27/2012 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125320s0054lbl.pdf
09/16/2011 SUPPL-6 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125320s5s6lbl.pdf
09/16/2011 SUPPL-5 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125320s5s6lbl.pdf
11/18/2010 SUPPL-7 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s007lbl.pdf
06/01/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s0000lbl.pdf

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