FDA Approval for OJEMDA issued to DAY ONE BIOPHARMACEUTICALS INC

$DAWN
Biotechnology: Pharmaceutical Preparations
Health Care
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New Drug Application (NDA): 217700
Company: DAY ONE BIOPHARMACEUTICALS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OJEMDA TOVORAFENIB 100MG TABLET;ORAL Prescription None No No
OJEMDA TOVORAFENIB 25MG/ML SUSPENSION; ORAL 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
04/23/2024 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/23/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217700s000lbl.pdf
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