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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761143
Company: HORIZON THERAPEUTICS IRELAND

Products on BLA 761143

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEPEZZA	TEPROTUMUMAB-TRBW	500MG	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761143

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/2020	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761143s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761143Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761143Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/13/2023	SUPPL-24	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761143s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761143Orig1s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761143Orig1s024MedR.pdf
07/17/2023	SUPPL-23	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761143s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761143Orig1s023ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761143Orig1s023.pdf
12/06/2022	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761143s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761143Orig1s021ltr.pdf
10/26/2021	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761143s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761143Orig1s014ltr.pdf

Labels for BLA 761143

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761143s023lbl.pdf
04/13/2023	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761143s024lbl.pdf
12/06/2022	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761143s021lbl.pdf
10/26/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761143s014lbl.pdf
01/21/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761143s000lbl.pdf

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