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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217677
Company: SPRINGWORKS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OGSIVEO NIROGACESTAT HYDROBROMIDE EQ 50MG BASE TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/2023 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217677Orig1s000_Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217677Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217677Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/27/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217677Orig1s000_Corrected_lbl.pdf
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