Approvals (Drugs@FDA)

OPDIVO

BRISTOL MYERS SQUIBB · NIVOLUMAB

BLA125554Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA125554
Sponsor name
BRISTOL MYERS SQUIBB
Submissions
  1. Submission type
    SUPPL
    Submission number
    119
    Submission status
    AP
    Submission status date
    20230215
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      73526
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125554Orig1s119ltr.pdf
      Date
      20230216
      Type
      Letter
    2. ID
      73537
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554s119lbl.pdf
      Date
      20230217
      Type
      Label
  2. Submission type
    SUPPL
    Submission number
    133
    Submission status
    AP
    Submission status date
    20250523
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      82335
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125554Orig1s133ltr.pdf
      Date
      20250528
      Type
      Letter
    2. ID
      82403
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s133lbl.pdf
      Date
      20250602
      Type
      Label
  3. Submission type
    SUPPL
    Submission number
    3
    Submission status
    AP
    Submission status date
    20150414
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      66325
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125554Orig1s003.pdf
      Date
      20210223
      Type
      Review
  4. Submission type
    SUPPL
    Submission number
    34
    Submission status
    AP
    Submission status date
    20170731
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      49172
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s034lbl.pdf
      Date
      20170801
      Type
      Label
    2. ID
      49209
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s034ltr.pdf
      Date
      20170802
      Type
      Letter
    3. ID
      64665
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125554Orig1s034.pdf
      Date
      20200924
      Type
      Review
  5. Submission type
    SUPPL
    Submission number
    125
    Submission status
    AP
    Submission status date
    20240306
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      77747
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s125lbl.pdf
      Date
      20240307
      Type
      Label
    2. ID
      77760
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125554Orig1s125ltr.pdf
      Date
      20240311
      Type
      Letter
  6. Submission type
    SUPPL
    Submission number
    40
    Submission status
    AP
    Submission status date
    20170906
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      49681
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s040lbl.pdf
      Date
      20170907
      Type
      Label
    2. ID
      49700
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s040ltr.pdf
      Date
      20170908
      Type
      Letter
  7. Submission type
    SUPPL
    Submission number
    1
    Submission status
    AP
    Submission status date
    20151123
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      39992
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s001lbl.pdf
      Date
      20151125
      Type
      Label
    2. ID
      9785
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s001ltr.pdf
      Date
      20151124
      Type
      Letter
  8. Submission type
    SUPPL
    Submission number
    117
    Submission status
    AP
    Submission status date
    20230215
    Review priority
    PRIORITY
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      73528
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125554Orig1s117ltr.pdf
      Date
      20230216
      Type
      Letter
    2. ID
      73540
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554s117lbl.pdf
      Date
      20230217
      Type
      Label
  9. Submission type
    SUPPL
    Submission number
    131
    Submission status
    AP
    Submission status date
    20250701
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      82723
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125554s131lbl.pdf
      Date
      20250702
      Type
      Label
    2. ID
      82725
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125554Orig1s131ltr.pdf
      Date
      20250702
      Type
      Letter
  10. Submission type
    SUPPL
    Submission number
    18
    Submission status
    AP
    Submission status date
    20160913
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      45324
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s017,s018ltr.pdf
      Date
      20160915
      Type
      Letter
    2. ID
      45403
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf
      Date
      20160928
      Type
      Label
  11. Submission type
    SUPPL
    Submission number
    85
    Submission status
    AP
    Submission status date
    20200918
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      64622
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s084, 125554Orig1s085ltr.pdf
      Date
      20200921
      Type
      Letter
    2. ID
      64691
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s084s085lbl.pdf
      Date
      20200925
      Type
      Label
  12. Submission type
    SUPPL
    Submission number
    109
    Submission status
    AP
    Submission status date
    20220225
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      70289
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125554Orig1s109ltr.pdf
      Date
      20220228
      Type
      Letter
    2. ID
      70348
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s109lbl.pdf
      Date
      20220302
      Type
      Label
  13. +73 more not shown
Products
  1. Product number
    001
    Reference drug
    TBD
    Brand name
    OPDIVO
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      NIVOLUMAB
      Strength
      40MG/4ML
Harmonized identifiers (openFDA)
Application number
BLA125554
Brand name
OPDIVO
Generic name
NIVOLUMAB
Manufacturer name
E.R. Squibb & Sons, L.L.C.
Product NDC
0003-3734, 0003-3772, 0003-3774, 0003-3756
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Substance name
NIVOLUMAB
RxCUI
1657190, 1657192, 1657195, 1657196, 1991412, 1991413, 2569080, 2569081
SPL ID
1fce9e6a-6a7c-4fc0-a3a4-a0099f7bd2ce
SPL set ID
f570b9c4-6846-4de2-abfa-4d0a4ae4e394
Package NDC
0003-3772-11, 0003-3774-12, 0003-3734-13, 0003-3756-14
Nui
N0000191260, N0000191259
Pharm class epc
Programmed Death Receptor-1 Blocking Antibody [EPC]
Pharm class moa
Programmed Death Receptor-1-directed Antibody Interactions [MoA]
UNII
31YO63LBSN
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

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.