Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125320
Company: AMGEN
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 |
|---|---|---|---|---|---|
| 04/09/2024 | SUPPL-218 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125320Orig1s218ltr.pdf |
| 03/05/2024 | SUPPL-217 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125320Orig1s217ltr.pdf |
| 01/19/2024 | SUPPL-216 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125320s216lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125320Orig1s216ltr.pdf | |
| 03/05/2024 | SUPPL-213 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125320s213lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125320Orig1s213ltr.pdf | |
| 01/03/2023 | SUPPL-211 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125320Orig1s211lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125320Orig1s211ltr.pdf | |
| 05/19/2022 | SUPPL-210 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125320s210lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125320Orig1s210ltr.pdf | |
| 05/12/2021 | SUPPL-207 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125320s207lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125320Orig1s207ltr.pdf | |
| 04/23/2020 | SUPPL-205 | Supplement |
Label (PDF)
Letter (PDF) |
Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125320s205lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125320Orig1s205ltr.pdf |
| 06/09/2020 | SUPPL-203 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125320s203lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125320Orig1s203ltr.pdf | |
| 10/01/2019 | SUPPL-202 | Supplement |
Label (PDF)
Letter (PDF) |
Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s202lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125320Orig1s202ltr.pdf |
| 02/10/2020 | SUPPL-201 | Supplement |
Label (PDF)
Letter (PDF) |
Label for XGEVA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125320s201lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125320Orig1s201ltr.pdf |
| 04/30/2019 | SUPPL-200 | Supplement |
Label (PDF)
Letter (PDF) |
Label for PROLIA | 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) |
Label for XGEVA | 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) |
Label for PROLIA | 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) |
Label for XGEVA | 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) |
Label for PROLIA | 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) |
Label for XGEVA | 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) |
Label for PROLIA | 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) |
Label for XGEVA | 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) |
Label for XGEVA | 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) |
Label for PROLIA | 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 |
|---|---|---|---|---|---|
| 03/05/2024 | SUPPL-213 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125320s213lbl.pdf | |
| 01/19/2024 | SUPPL-216 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125320s216lbl.pdf | |
| 01/19/2024 | SUPPL-216 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125320s216lbl.pdf | |
| 01/03/2023 | SUPPL-211 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125320Orig1s211lbl.pdf | |
| 01/03/2023 | SUPPL-211 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125320Orig1s211lbl.pdf | |
| 05/19/2022 | SUPPL-210 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125320s210lbl.pdf | |
| 05/19/2022 | SUPPL-210 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125320s210lbl.pdf | |
| 05/19/2022 | SUPPL-210 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125320s210lbl.pdf | |
| 05/12/2021 | SUPPL-207 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125320s207lbl.pdf | |
| 06/09/2020 | SUPPL-203 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125320s203lbl.pdf | |
| 04/23/2020 | SUPPL-205 | Labeling-Package Insert | Label (PDF) | Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125320s205lbl.pdf |
| 02/10/2020 | SUPPL-201 | Labeling-Package Insert | Label (PDF) | Label for XGEVA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125320s201lbl.pdf |
| 10/01/2019 | SUPPL-202 | REMS - MODIFIED - D-N-A | Label (PDF) | Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s202lbl.pdf |
| 07/26/2019 | SUPPL-198 | Labeling-Package Insert | Label (PDF) | Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s198lbl.pdf |
| 07/26/2019 | SUPPL-198 | Labeling-Medication Guide | Label (PDF) | Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s198lbl.pdf |
| 05/24/2019 | SUPPL-195 | Labeling-Package Insert | Label (PDF) | Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s195lbl.pdf |
| 05/08/2019 | SUPPL-199 | Labeling-Package Insert | Label (PDF) | Label for XGEVA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s196s199lbl.pdf |
| 05/08/2019 | SUPPL-196 | Labeling-Package Insert | Label (PDF) | Label for XGEVA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s196s199lbl.pdf |
| 04/30/2019 | SUPPL-200 | REMS-Modified | Label (PDF) | Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s200lbl.pdf |
| 04/30/2019 | SUPPL-200 | Labeling-Package Insert | Label (PDF) | Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s200lbl.pdf |
| 04/30/2019 | SUPPL-200 | Labeling-Medication Guide | Label (PDF) | Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125320s200lbl.pdf |
| 06/07/2018 | SUPPL-191 | Labeling-Package Insert | Label (PDF) | Label for XGEVA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s191lbl.pdf |
| 05/18/2018 | SUPPL-186 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | Label for PROLIA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s186lbl.pdf |
| 01/24/2018 | SUPPL-185 | Labeling-Package Insert | Label (PDF) | Label for XGEVA | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125320s185lbl.pdf |
| 01/04/2018 | SUPPL-182 | Efficacy-New Indication | Label (PDF) | Label for XGEVA | 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) | Label for PROLIA | 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 |