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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125268
Company: AMGEN

Medication Guide

Summary Review

Products on BLA 125268

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125268

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

Labels for BLA 125268

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

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