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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761219
Company: CELLTRION
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
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
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761219s002lbl.pdf
11/30/2023 SUPPL-2 Labeling-Package Insert 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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