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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218820
Company: NEUROCRINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CRENESSITY CRINECERFONT 50MG/ML SOLUTION;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
12/13/2024 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218808s000,218820s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218808Orig1s000,218820Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/218808Orig1s000,218820Orig1s000TOC.html

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/13/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218808s000,218820s000lbl.pdf
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