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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761219
Company: CELLTRION

Medication Guide

Products on BLA 761219

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
YUFLYMA	ADALIMUMAB-AATY	40MG/0.4ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761219

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2023	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761219Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2023	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s006; s007; s008ltr.pdf
12/22/2023	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s006; s007; s008ltr.pdf
12/22/2023	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s006; s007; s008ltr.pdf
09/21/2023	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s004ltr.pdf
09/06/2023	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s003ltr.pdf
11/30/2023	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761219Orig1s002ltr.pdf
10/02/2023	SUPPL-1	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s001lbl.pdf

Labels for BLA 761219

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf
12/22/2023	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf
12/22/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf
12/22/2023	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf
12/22/2023	SUPPL-6	Bioequivalence	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s006s007s008lbl.pdf
11/30/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s002lbl.pdf
11/30/2023	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s002lbl.pdf
10/02/2023	SUPPL-1	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s001lbl.pdf
09/21/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s004lbl.pdf
09/21/2023	SUPPL-4	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s004lbl.pdf
09/06/2023	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s003lbl.pdf
09/06/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219Orig1s003lbl.pdf
05/23/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s000lbl.pdf

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