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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218201
Company: SEBELA WOMENS HLTH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIUDELLA COPPER N/A SYSTEM;INTRAUTERINE 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
02/24/2025 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218201Correcteds000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218201Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/01/2025 SUPPL-2 REMS - MODIFIED - D-N-A Letter (PDF)
Letter (PDF)
Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218201Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218201Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218201Orig1s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/24/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218201Correcteds000lbl.pdf
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