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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761059
Company: SAMSUNG BIOEPIS CO LTD

Medication Guide

Products on BLA 761059

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HADLIMA	ADALIMUMAB-BWWD	40MG/0.8ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761059

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761059s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761059Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761059Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2023	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761059Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761059Orig1s013ltr.pdf
07/11/2023	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761059s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761059Orig1s008ltr.pdf
12/23/2022	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761059Orig1s007ltr.pdf
06/26/2023	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761059s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761059Orig1s006ltr.pdf
08/15/2022	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761059Orig1s005ltr.pdf
06/17/2022	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761059Orig1s004ltr.pdf

Labels for BLA 761059

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2023	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761059s008lbl.pdf
06/26/2023	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761059s006lbl.pdf
04/26/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761059Orig1s013lbl.pdf
12/23/2022	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059Orig1s007lbl.pdf
08/15/2022	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s005lbl.pdf
06/17/2022	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s004lbl.pdf
06/17/2022	SUPPL-4	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761059s004lbl.pdf
07/23/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761059s000lbl.pdf

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