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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125526
Company: GLAXOSMITHKLINE LLC

Summary Review

Products on BLA 125526

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUCALA	MEPOLIZUMAB	100MG	INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125526

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/04/2015	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125526Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125526Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125526Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2023	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125526Orig1s021,761122Orig1s011Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125526Orig1s021;761122Orig1s011Corrected_ltr.pdf
01/22/2022	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761122s008,125526s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125526Orig1s019; 761122Orig1s008ltr.pdf
07/29/2021	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761122Orig1s006; 125526Orig1s018ltr.pdf
09/25/2020	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125526s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125526Orig1s017ltr.pdf
06/06/2019	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125526Orig1s013ltr.pdf
09/12/2019	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125526Orig1s012, 761122Orig1s002,s003ltr.pdf
12/12/2017	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125526Orig1s004ltr.pdf
02/16/2017	SUPPL-2	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s002lbl.pdf

Labels for BLA 125526

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/08/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125526Orig1s021,761122Orig1s011Corrected_lbl.pdf
01/22/2022	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761122s008,125526s019lbl.pdf
07/29/2021	SUPPL-18	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf
09/25/2020	SUPPL-17	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125526s017lbl.pdf
09/12/2019	SUPPL-12	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf
06/06/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s013lbl.pdf
12/12/2017	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s004lbl.pdf
02/16/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125526s002lbl.pdf
11/04/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf

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