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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761154
Company: MYLAN PHARMS INC

Medication Guide

Products on BLA 761154

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HULIO	ADALIMUMAB-FKJP	20MG;0.4ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761154

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/2020	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761154s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761154Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761154Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761154Orig1s008ltr.pdf
08/25/2023	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761154Orig1s005ltr.pdf
03/03/2023	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761154orig1s003ltr.pdf
07/14/2022	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761154s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761154Orig1s002ltr.pdf

Labels for BLA 761154

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154Orig1s008lbl.pdf
12/15/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154Orig1s008lbl.pdf
12/15/2023	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154Orig1s008lbl.pdf
08/25/2023	SUPPL-5	Bioequivalence	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154s005lbl.pdf
03/03/2023	SUPPL-3		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761154s003lbl.pdf
07/14/2022	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761154s002lbl.pdf
07/06/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761154s000lbl.pdf

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