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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217639
Company: STEMLINE THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORSERDU ELACESTRANT DIHYDROCHLORIDE EQ 86MG BASE TABLET;ORAL Prescription None Yes No
ORSERDU ELACESTRANT DIHYDROCHLORIDE EQ 345MG 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
01/27/2023 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s000correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217639Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217639Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/27/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/217639Orig1s000correctedlbl.pdf
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