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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761399
Company: CELLTRION INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMLYCLO OMALIZUMAB-IGEC 75MG/0.5ML INJECTABLE;INJECTION Prescription None No No
OMLYCLO OMALIZUMAB-IGEC 150MG/ML 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
03/07/2025 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761399s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761399Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/07/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761399s000lbl.pdf
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