Approvals (Drugs@FDA)

OZEMPIC, RYBELSUS

NOVO · SEMAGLUTIDE

NDA213051Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA213051
Sponsor name
NOVO
Submissions
  1. Submission type
    SUPPL
    Submission number
    29
    Submission status
    AP
    Submission status date
    20251017
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      83832
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf
      Date
      20251020
      Type
      Label
    2. ID
      83857
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf
      Date
      20251021
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20200116
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      61591
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213182s000,213051s001lbl.pdf
      Date
      20200117
      Type
      Label
    2. ID
      61603
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213182Orig1s000, 213051Orig1s001ltr.pdf
      Date
      20200117
      Type
      Letter
  3. Submission type
    SUPPL
    Submission number
    23
    Submission status
    AP
    Submission status date
    20241101
    Review priority
    901 REQUIRED
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      80128
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s023ltr.pdf
      Date
      20241105
      Type
      Letter
    2. ID
      80140
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s023lbl.pdf
      Date
      20241105
      Type
      Label
  4. Submission type
    SUPPL
    Submission number
    21
    Submission status
    AP
    Submission status date
    20241209
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      80545
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051Orig1s020,213051Orig1s021lbl.pdf
      Date
      20250211
      Type
      Label
    2. ID
      80551
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s020,213051Orig1s021ltr.pdf
      Date
      20241210
      Type
      Letter
  5. Submission type
    SUPPL
    Submission number
    11
    Submission status
    AP
    Submission status date
    20220610
    Review priority
    901 REQUIRED
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      71296
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213051s011lbl.pdf
      Date
      20220614
      Type
      Label
    2. ID
      71305
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213051Orig1s011ltr.pdf
      Date
      20220614
      Type
      Letter
  6. Submission type
    SUPPL
    Submission number
    6
    Submission status
    AP
    Submission status date
    20210430
    Review priority
    N/A
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      67412
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213051s006lbl.pdf
      Date
      20210505
      Type
      Label
  7. Submission type
    SUPPL
    Submission number
    28
    Submission status
    AP
    Submission status date
    20251017
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      83830
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf
      Date
      20251020
      Type
      Label
    2. ID
      83856
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf
      Date
      20251021
      Type
      Letter
  8. Submission type
    SUPPL
    Submission number
    18
    Submission status
    AP
    Submission status date
    20240124
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      77291
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s018ltr.pdf
      Date
      20240125
      Type
      Letter
    2. ID
      77299
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213051s018lbl.pdf
      Date
      20240125
      Type
      Label
  9. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20190920
    Review priority
    PRIORITY
    Submission class code
    TYPE 3
    Submission class code description
    Type 3 - New Dosage Form
    Application docs
    1. ID
      60077
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213051s000lbl.pdf
      Date
      20190920
      Type
      Label
    2. ID
      60094
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213051Orig1s000ltr.pdf
      Date
      20190924
      Type
      Letter
    3. ID
      63478
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213051Orig1s000TOC.html
      Date
      20200610
      Type
      Review
  10. Submission type
    SUPPL
    Submission number
    24
    Submission status
    AP
    Submission status date
    20251017
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      83828
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf
      Date
      20251020
      Type
      Label
    2. ID
      83829
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051s024,s028s029lbl.pdf#page=27
      Date
      20251020
      Type
      Medication Guide
    3. ID
      83854
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf
      Date
      20251021
      Type
      Letter
    4. ID
      83855
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213051Orig1s024,s028,s029ltr.pdf
      Date
      20251021
      Type
      Letter
  11. Submission type
    SUPPL
    Submission number
    30
    Submission status
    AP
    Submission status date
    20260130
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      84895
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213051Orig1s030ltr.pdf
      Date
      20260203
      Type
      Letter
    2. ID
      84949
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213051Orig1s030lbl.pdf
      Date
      20260731
      Type
      Label
  12. Submission type
    SUPPL
    Submission number
    20
    Submission status
    AP
    Submission status date
    20241209
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      80546
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213051Orig1s020,213051Orig1s021lbl.pdf
      Date
      20250211
      Type
      Label
    2. ID
      80550
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213051Orig1s020,213051Orig1s021ltr.pdf
      Date
      20241210
      Type
      Letter
  13. +1 more not shown
Products
  1. Product number
    006
    Reference drug
    Yes
    Brand name
    OZEMPIC
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      9MG
  2. Product number
    004
    Reference drug
    Yes
    Brand name
    OZEMPIC
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      1.5MG
  3. Product number
    002
    Reference drug
    Yes
    Brand name
    RYBELSUS
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      7MG
  4. Product number
    005
    Reference drug
    Yes
    Brand name
    OZEMPIC
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      4MG
  5. Product number
    003
    Reference drug
    Yes
    Brand name
    RYBELSUS
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      14MG
  6. Product number
    001
    Reference drug
    Yes
    Brand name
    RYBELSUS
    Reference standard
    Yes
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      SEMAGLUTIDE
      Strength
      3MG
Harmonized identifiers (openFDA)
Application number
NDA213051
Brand name
OZEMPIC, RYBELSUS
Generic name
ORAL SEMAGLUTIDE
Manufacturer name
Novo Nordisk Pharmaceutical Industries, LP
Product NDC
0169-1704, 0169-1715, 0169-1709, 0169-4303, 0169-4307, 0169-4314, 0169-4815, 0169-4804, 0169-4809
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
SEMAGLUTIDE
RxCUI
2200644, 2200650, 2200652, 2200654, 2200656, 2200658, 2707547, 2707549, 2707551, 2707553, 2707555, 2707557, 2736944, 2736946, 2736948
SPL ID
6834044a-22f1-4f35-b846-b3448ee84c16
SPL set ID
27f15fac-7d98-4114-a2ec-92494a91da98
Package NDC
0169-1715-30, 0169-1715-90, 0169-1704-30, 0169-1709-30, 0169-4303-01, 0169-4303-13, 0169-4303-90, 0169-4303-93, 0169-4303-30, 0169-4303-99, 0169-4307-01, 0169-4307-13, 0169-4307-30, 0169-4314-01, 0169-4314-13, 0169-4314-30, 0169-4815-30, 0169-4815-90, 0169-4804-30, 0169-4809-30
Nui
N0000178480, M0160181, N0000020058
Pharm class epc
GLP-1 Receptor Agonist [EPC]
Pharm class cs
Glucagon-Like Peptide 1 [CS]
Pharm class moa
Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
UNII
53AXN4NNHX
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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.