Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Biologic License Application (BLA): 125268
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
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English