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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761275
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYENNE TOCILIZUMAB-AAZG 162MG/0.9ML INJECTABLE;SUBCUTANEOUS Prescription None No No
TYENNE TOCILIZUMAB-AAZG 80MG/4ML INJECTABLE;INTRAVENOUS Prescription None No No
TYENNE TOCILIZUMAB-AAZG 200MG/10ML INJECTABLE;INTRAVENOUS Prescription None No No
TYENNE TOCILIZUMAB-AAZG 400MG/20ML INJECTABLE;INTRAVENOUS 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
03/05/2024 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275Orig1s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761275Orig1s000Correctedltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/05/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761275Orig1s000Correctedlbl.pdf
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