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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761083
Company: GENENTECH INC

Medication Guide

Products on BLA 761083

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HEMLIBRA	EMICIZUMAB	30MG/ML	INJECTABLE;INJECTION	Prescription	None	TBD	No
HEMLIBRA	EMICIZUMAB	60MG/0.4ML	INJECTABLE;INJECTION	Prescription	None	TBD	No
HEMLIBRA	EMICIZUMAB	105MG/0.7ML	INJECTABLE;INJECTION	Prescription	None	TBD	No
HEMLIBRA	EMICIZUMAB	150MG	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761083

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2017	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761083s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761083Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761083Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/31/2024	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761083s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761083Orig1s018ltr.pdf
06/06/2022	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761083s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761083Orig1s015ltr.pdf
12/16/2021	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761083s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761083Orig1s013ltr.pdf
09/02/2021	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761083s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761083Orig1s011ltr.pdf
10/04/2018	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761083Orig1s002,761083Orig1s004Ltr.pdf
10/04/2018	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761083Orig1s002,761083Orig1s004Ltr.pdf

Labels for BLA 761083

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/31/2024	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761083s018lbl.pdf
01/31/2024	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761083s018lbl.pdf
06/06/2022	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761083s015lbl.pdf
12/16/2021	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761083s013lbl.pdf
12/16/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761083s013lbl.pdf
09/02/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761083s011lbl.pdf
10/04/2018	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf
10/04/2018	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761083s002s004lbl.pdf
11/16/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761083s000lbl.pdf

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