Approvals (Drugs@FDA)

WEGOVY

NOVO · SEMAGLUTIDE

NDA218316Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA218316
Sponsor name
NOVO
Submissions
  1. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20260225
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      85179
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s033,218316Orig1s004ltr.pdf
      Date
      20260227
      Type
      Letter
    2. ID
      85194
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s004lbl.pdf
      Date
      20260302
      Type
      Label
  2. Submission type
    SUPPL
    Submission number
    2
    Submission status
    AP
    Submission status date
    20260129
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      84886
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s030;218316Orig1s002ltr.pdf
      Date
      20260130
      Type
      Letter
    2. ID
      84941
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s002lbl.pdf
      Date
      20260205
      Type
      Label
  3. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20251222
    Review priority
    STANDARD
    Submission class code
    TYPE 3
    Submission class code description
    Type 3 - New Dosage Form
    Application docs
    1. ID
      84499
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s031,218316s00lbl.pdf
      Date
      20260908
      Type
      Label
    2. ID
      84543
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256s031,218316s00ltr.pdf
      Date
      20251223
      Type
      Letter
    3. ID
      87243
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218316Orig1s000TOC.html
      Date
      20260921
      Type
      Review
  4. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20260618
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      86340
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s007lbl.pdf
      Date
      20260623
      Type
      Label
  5. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20260319
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      85453
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s029;218316Orig1s005ltr.pdf
      Date
      20260323
      Type
      Letter
    2. ID
      85500
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256Orig1s029, 218316Orig1s005lbl.pdf
      Date
      20260324
      Type
      Label
    3. ID
      85516
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218316s005lbl.pdf#page=51
      Date
      20260324
      Type
      Medication Guide
  6. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20260505
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      85893
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s031lbl218316s003lbl.pdf
      Date
      20260512
      Type
      Label
Products
  1. Product number
    003
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      9MG
  2. Product number
    001
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      1.5MG
  3. Product number
    004
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      25MG
  4. Product number
    002
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      4MG
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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.