Approvals (Drugs@FDA)

MIUDELLA

SEBELA WOMENS HLTH · COPPER

NDA218201Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA218201
Sponsor name
SEBELA WOMENS HLTH
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250224
    Review priority
    STANDARD
    Submission class code
    TYPE 5
    Submission class code description
    Type 5 - New Formulation or New Manufacturer
    Application docs
    1. ID
      81343
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218201Correcteds000lbl.pdf
      Date
      20250225
      Type
      Label
    2. ID
      81368
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218201Orig1s000ltr.pdf
      Date
      20250225
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20251001
    Review priority
    N/A
    Submission class code
    REMS
    Submission class code description
    REMS
    Application docs
    1. ID
      83635
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218201Orig1s002ltr.pdf
      Date
      20251003
      Type
      Letter
    2. ID
      83636
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218201Orig1s002ltr.pdf
      Date
      20251003
      Type
      Letter
    3. ID
      83637
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218201Orig1s002ltr.pdf
      Date
      20251003
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    Yes
    Brand name
    MIUDELLA
    Reference standard
    Yes
    Dosage form
    SYSTEM
    Route
    INTRAUTERINE
    Marketing status
    Prescription
    Active ingredients
    1. Name
      COPPER
      Strength
      N/A
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.