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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761299
Company: ALVOTECH USA INC
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
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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