Approvals (Drugs@FDA)

RYBELSUS

NOVO NORDISK INC · SEMAGLUTIDE

NDA213182Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA213182
Sponsor name
NOVO NORDISK INC
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20200116
    Review priority
    STANDARD
    Submission class code
    TYPE 9
    Submission class code description
    Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
    Application docs
    1. ID
      61589
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf
      Date
      20200117
      Type
      Label
    2. ID
      61590
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf#page=23
      Date
      20200117
      Type
      Medication Guide
    3. ID
      61602
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213182Orig1s000, 213051Orig1s001ltr.pdf
      Date
      20200117
      Type
      Letter
    4. ID
      63744
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213182Orig1s000TOC.html
      Date
      20200629
      Type
      Review
Products
  1. Product number
    001
    Reference drug
    TBD
    Brand name
    RYBELSUS
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      3MG
  2. Product number
    002
    Reference drug
    TBD
    Brand name
    RYBELSUS
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      7MG
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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.