Approvals (Drugs@FDA)

OZEMPIC

NOVO · SEMAGLUTIDE

NDA209637Drug (NDA)PrescriptionDiscontinued
Open FDA's page for this record
Application number
NDA209637
Sponsor name
NOVO
Submissions
  1. Submission type
    SUPPL
    Submission number
    21
    Submission status
    AP
    Submission status date
    20230922
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      75551
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209637Orig1s020,s021ltr.pdf
      Date
      20230925
      Type
      Letter
    2. ID
      75555
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209637s020s021lbl.pdf
      Date
      20230925
      Type
      Label
  2. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20171205
    Review priority
    STANDARD
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Application docs
    1. ID
      50622
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
      Date
      20171206
      Type
      Label
    2. ID
      50623
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209637s000ltr.pdf
      Date
      20171207
      Type
      Letter
    3. ID
      51050
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209637Orig1s000TOC.html
      Date
      20180116
      Type
      Review
  3. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20200116
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      61593
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209637s003lbl.pdf
      Date
      20200117
      Type
      Label
    2. ID
      61599
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209637Orig1s003ltr.pdf
      Date
      20200117
      Type
      Letter
  4. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20190409
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      58271
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s001lbl.pdf
      Date
      20190410
      Type
      Label
    2. ID
      58289
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209637Orig1s001ltr.pdf
      Date
      20190411
      Type
      Letter
  5. Submission type
    SUPPL
    Submission number
    38
    Submission status
    AP
    Submission status date
    20260601
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      86129
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/209637Orig1s038ltr.pdf
      Date
      20260602
      Type
      Letter
    2. ID
      86202
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637s038lbl.pdf
      Date
      20260610
      Type
      Label
  6. Submission type
    SUPPL
    Submission number
    44
    Submission status
    AP
    Submission status date
    20260827
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      87064
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/209637Orig1s044ltr.pdf
      Date
      20260828
      Type
      Letter
    2. ID
      87073
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637Orig1s044lbl.pdf
      Date
      20260828
      Type
      Label
  7. Submission type
    SUPPL
    Submission number
    32
    Submission status
    AP
    Submission status date
    20241101
    Review priority
    901 REQUIRED
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      80127
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209637Orig1s032ltr.pdf
      Date
      20241105
      Type
      Letter
    2. ID
      80142
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209637s032lbl.pdf
      Date
      20241105
      Type
      Label
    3. ID
      85118
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/209637Orig1s032.pdf
      Date
      20260224
      Type
      Review
  8. Submission type
    SUPPL
    Submission number
    8
    Submission status
    AP
    Submission status date
    20210412
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      67048
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209637Orig1s008ltr.pdf
      Date
      20210413
      Type
      Letter
    2. ID
      67060
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209637s008lbl.pdf
      Date
      20210414
      Type
      Label
  9. Submission type
    SUPPL
    Submission number
    20
    Submission status
    AP
    Submission status date
    20230922
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      75550
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209637Orig1s020,s021ltr.pdf
      Date
      20230925
      Type
      Letter
    2. ID
      75556
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209637s020s021lbl.pdf
      Date
      20230925
      Type
      Label
  10. Submission type
    SUPPL
    Submission number
    12
    Submission status
    AP
    Submission status date
    20221006
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      72275
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209637Orig1s012ltr.pdf
      Date
      20221007
      Type
      Letter
    2. ID
      72295
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s012lbl.pdf
      Date
      20221011
      Type
      Label
  11. Submission type
    SUPPL
    Submission number
    4
    Submission status
    AP
    Submission status date
    20191127
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      61094
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209637Orig1s004ltr.pdf
      Date
      20191129
      Type
      Letter
    2. ID
      61112
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s004lbl.pdf
      Date
      20191202
      Type
      Label
  12. Submission type
    SUPPL
    Submission number
    39
    Submission status
    AP
    Submission status date
    20260505
    Review priority
    N/A
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      87160
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/209637Orig1s039ltr.pdf
      Date
      20260908
      Type
      Letter
    2. ID
      87165
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209637Orig1s039lbl.pdf
      Date
      20260908
      Type
      Label
  13. +4 more not shown
Products
  1. Product number
    003
    Reference drug
    Yes
    Brand name
    OZEMPIC
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      8MG/3ML (2.68MG/ML)
  2. Product number
    001
    Reference drug
    Yes
    Brand name
    OZEMPIC
    Reference standard
    No
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Discontinued
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      2MG/1.5ML (1.34MG/ML)
  3. Product number
    006
    Reference drug
    Yes
    Brand name
    OZEMPIC
    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)
  4. Product number
    004
    Reference drug
    Yes
    Brand name
    OZEMPIC
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      2MG/3ML (0.68MG/ML)
  5. Product number
    002
    Reference drug
    Yes
    Brand name
    OZEMPIC
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      4MG/3ML (1.34MG/ML)
  6. Product number
    007
    Reference drug
    Yes
    Brand name
    OZEMPIC
    Reference standard
    Yes
    Dosage form
    SOLUTION
    Route
    SUBCUTANEOUS
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      1MG/0.5ML (1MG/0.5ML)
  7. Product number
    005
    Reference drug
    Yes
    Brand name
    OZEMPIC
    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)
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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.