Approvals (Drugs@FDA)

WEGOVY, WEGOVY HD, WEGOVY FLEXTOUCH

NOVO · SEMAGLUTIDE

NDA215256Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA215256
Sponsor name
NOVO
Submissions
  1. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20240308
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      77770
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s011lbl.pdf
      Date
      20240308
      Type
      Label
    2. ID
      77775
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215256Orig1s011ltr.pdf
      Date
      20240311
      Type
      Letter
    3. ID
      80167
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/215256Orig1s011.pdf
      Date
      20241105
      Type
      Review
  2. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20230214
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      73507
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256Orig1s006lbl.pdf
      Date
      20230215
      Type
      Label
    2. ID
      73508
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215256Orig1s006ltr.pdf
      Date
      20230216
      Type
      Letter
  3. Submission type
    SUPPL
    Submission number
    26
    Submission status
    AP
    Submission status date
    20251014
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      83774
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215256Orig1s026ltr.pdf
      Date
      20251015
      Type
      Letter
    2. ID
      83779
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s026lbl.pdf
      Date
      20251015
      Type
      Label
  4. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20210604
    Review priority
    PRIORITY
    Submission class code
    TYPE 10
    Submission class code description
    Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
    Application docs
    1. ID
      67724
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf
      Date
      20210607
      Type
      Label
    2. ID
      67729
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215256Orig1s000ltr.pdf
      Date
      20210607
      Type
      Letter
    3. ID
      69772
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215256Orig1s000TOC.html
      Date
      20211227
      Type
      Review
  5. Submission type
    SUPPL
    Submission number
    24
    Submission status
    AP
    Submission status date
    20250815
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      83106
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215256s024lbl.pdf
      Date
      20250815
      Type
      Label
    2. ID
      83118
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215256Orig1s024ltr.pdf
      Date
      20250818
      Type
      Letter
  6. Submission type
    SUPPL
    Submission number
    30
    Submission status
    AP
    Submission status date
    20260129
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      84885
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s030;218316Orig1s002ltr.pdf
      Date
      20260130
      Type
      Letter
    2. ID
      84943
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s030lbl.pdf
      Date
      20260129
      Type
      Label
  7. Submission type
    SUPPL
    Submission number
    7
    Submission status
    AP
    Submission status date
    20230721
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      74868
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215256Orig1s007ltr.pdf
      Date
      20230724
      Type
      Letter
    2. ID
      74874
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s007lbl.pdf
      Date
      20230724
      Type
      Label
  8. Submission type
    SUPPL
    Submission number
    5
    Submission status
    AP
    Submission status date
    20221223
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      73036
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s005lbl.pdf
      Date
      20221227
      Type
      Label
    2. ID
      73054
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215256Orig1s005ltr.pdf
      Date
      20221227
      Type
      Letter
  9. Submission type
    SUPPL
    Submission number
    29
    Submission status
    AP
    Submission status date
    20260319
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      85452
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s029;218316Orig1s005ltr.pdf
      Date
      20260323
      Type
      Letter
    2. ID
      85499
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256Orig1s029, 218316Orig1s005lbl.pdf
      Date
      20260824
      Type
      Label
    3. ID
      85515
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s029lbl.pdf#page=51
      Date
      20260324
      Type
      Medication Guide
  10. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20220824
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      71941
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215256s003lbl.pdf
      Date
      20220829
      Type
      Label
  11. Submission type
    SUPPL
    Submission number
    33
    Submission status
    AP
    Submission status date
    20260225
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      85178
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215256Orig1s033,218316Orig1s004ltr.pdf
      Date
      20260227
      Type
      Letter
    2. ID
      85190
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s033lbl.pdf
      Date
      20260302
      Type
      Label
  12. Submission type
    SUPPL
    Submission number
    25
    Submission status
    AP
    Submission status date
    20260618
    Review priority
    N/A
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      86339
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215256s025lbl.pdf
      Date
      20260623
      Type
      Label
  13. +4 more not shown
Products
  1. Product number
    009
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      1MG/0.5ML (1MG/0.5ML)
  2. Product number
    007
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      0.25MG/0.5ML (0.25MG/0.5ML)
  3. Product number
    005
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      2.4MG/0.75ML (2.4MG/0.75ML)
  4. Product number
    011
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      2.4MG/0.75ML (2.4MG/0.75ML)
  5. Product number
    003
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      1MG/0.5ML (1MG/0.5ML)
  6. Product number
    001
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      0.25MG/0.5ML (0.25MG/0.5ML)
  7. Product number
    008
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      0.5MG/0.5ML (0.5MG/0.5ML)
  8. Product number
    006
    Reference drug
    Yes
    Brand name
    WEGOVY HD
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      7.2MG/0.75ML (7.2MG/0.75ML)
  9. Product number
    012
    Reference drug
    Yes
    Brand name
    WEGOVY FLEXTOUCH
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      9.6MG/3ML (3.2MG/ML)
  10. Product number
    004
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      1.7MG/0.75ML (1.7MG/0.75ML)
  11. Product number
    010
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      1.7MG/0.75ML (1.7MG/0.75ML)
  12. Product number
    002
    Reference drug
    Yes
    Brand name
    WEGOVY
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      0.5MG/0.5ML (0.5MG/0.5ML)
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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.