Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125268
Company: AMGEN
Company: AMGEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NPLATE | ROMIPLOSTIM | 250MCG/0.5ML; 500MCG/1ML. | INJECTABLE; SUBCUTANEOUS | Prescription | None | TBD | 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 |
---|---|---|---|---|---|---|---|
08/22/2008 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125268lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125268s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125268_romiplostim_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125268s000_sumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/10/2022 | SUPPL-172 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125268s172lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125268Orig1s172ltr.pdf | |
01/29/2021 | SUPPL-170 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125268Orig1s170ltr.pdf |
11/23/2020 | SUPPL-169 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125268s169lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125268Orig1s169ltr.pdf | |
02/10/2021 | SUPPL-168 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125268s168lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125268Orig1s168ltr.pdf | |
01/28/2021 | SUPPL-167 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125268s167lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125268Orig1s167ltr.pdf | |
10/17/2019 | SUPPL-164 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125268s164lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125268Orig1s164ltr.pdf | |
12/14/2018 | SUPPL-163 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125268s163lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125268Orig1s163ltr.pdf | |
06/05/2017 | SUPPL-160 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125268s160lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125268Orig1s160ltr.pdf | |
04/19/2016 | SUPPL-156 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125268s155s156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125268Orig1s155,s156ltr.pdf | |
04/19/2016 | SUPPL-155 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125268s155s156lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125268Orig1s155,s156ltr.pdf | |
02/10/2014 | SUPPL-141 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125268s141lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125268Orig1s141ltr.pdf | |
05/30/2013 | SUPPL-121 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125268s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125268Orig1s121ltr.pdf | |
11/02/2012 | SUPPL-106 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125268s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125268Orig1s106ltr.pdf | |
12/06/2011 | SUPPL-77 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125268s077lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125268s077ltr.pdf | |
06/21/2011 | SUPPL-73 | Supplement |
Label is not available on this site. |
||
03/23/2010 | SUPPL-36 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125268s28s36ltr.pdf |
09/18/2009 | SUPPL-32 | Supplement |
Label is not available on this site. |
||
03/23/2010 | SUPPL-28 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125268s28s36ltr.pdf |
08/14/2009 | SUPPL-26 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125268s0026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125268s0026ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/10/2022 | SUPPL-172 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125268s172lbl.pdf | |
02/10/2022 | SUPPL-172 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125268s172lbl.pdf | |
02/10/2021 | SUPPL-168 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125268s168lbl.pdf | |
01/28/2021 | SUPPL-167 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125268s167lbl.pdf | |
11/23/2020 | SUPPL-169 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125268s169lbl.pdf | |
10/17/2019 | SUPPL-164 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125268s164lbl.pdf | |
12/14/2018 | SUPPL-163 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125268s163lbl.pdf | |
06/05/2017 | SUPPL-160 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125268s160lbl.pdf | |
04/19/2016 | SUPPL-156 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125268s155s156lbl.pdf | |
04/19/2016 | SUPPL-155 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125268s155s156lbl.pdf | |
02/10/2014 | SUPPL-141 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125268s141lbl.pdf | |
05/30/2013 | SUPPL-121 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125268s121lbl.pdf | |
11/02/2012 | SUPPL-106 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125268s106lbl.pdf | |
12/06/2011 | SUPPL-77 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125268s077lbl.pdf | |
08/14/2009 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125268s0026lbl.pdf | |
08/22/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125268lbl.pdf |