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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761299
Company: ALVOTECH USA INC

Medication Guide

Products on BLA 761299

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761299

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761299Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761299Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2025	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761299Orig1s025ltr.pdf
11/06/2025	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761299Orig1s024ltr.pdf
04/07/2025	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s013s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761299Orig1s013, s020ltr.pdf
02/14/2025	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761299Orig1s016ltr.pdf
04/07/2025	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s013s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761299Orig1s013, s020ltr.pdf
06/26/2024	SUPPL-7	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761299Orig1s007correctedltr.pdf
08/26/2024	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s003s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761299Orig1s003, s006ltr.pdf
08/26/2024	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s003s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761299Orig1s003, s006ltr.pdf
05/31/2024	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761299Orig1s001ltr.pdf

Labels for BLA 761299

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2025	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s024lbl.pdf
10/16/2025	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s025lbl.pdf
10/16/2025	SUPPL-25	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s025lbl.pdf
04/07/2025	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s013s020lbl.pdf
04/07/2025	SUPPL-13	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s013s020lbl.pdf
02/14/2025	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761299s016lbl.pdf
08/26/2024	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s003s006lbl.pdf
08/26/2024	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s003s006lbl.pdf
08/26/2024	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s003s006lbl.pdf
08/26/2024	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s003s006lbl.pdf
08/26/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s003s006lbl.pdf
08/26/2024	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s003s006lbl.pdf
05/31/2024	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s001lbl.pdf
02/23/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761299s000lbl.pdf

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