Approvals (Drugs@FDA)

STELARA

CENTOCOR ORTHO BIOTECH INC · USTEKINUMAB

BLA125261Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA125261
Sponsor name
CENTOCOR ORTHO BIOTECH INC
Submissions
  1. Submission type
    SUPPL
    Submission number
    147
    Submission status
    AP
    Submission status date
    20180608
    Review priority
    901 REQUIRED
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      54539
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s147lbl.pdf
      Date
      20180612
      Type
      Label
    2. ID
      54589
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125261Orig1s147ltr.pdf
      Date
      20180614
      Type
      Letter
  2. Submission type
    SUPPL
    Submission number
    161
    Submission status
    AP
    Submission status date
    20220729
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      71672
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125261Orig1s161ltr.pdf
      Date
      20220801
      Type
      Letter
    2. ID
      71693
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125261s161lbl.pdf
      Date
      20220802
      Type
      Label
  3. Submission type
    SUPPL
    Submission number
    153
    Submission status
    AP
    Submission status date
    20200406
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      64407
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125261Orig1s153, 761044s005lbl.pdf
      Date
      20200407
      Type
      Label
  4. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20090925
    Review priority
    STANDARD
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Application docs
    1. ID
      39877
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125261lbl.pdf
      Date
      20090929
      Type
      Label
    2. ID
      43312
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000TOC.html
      Date
      20100122
      Type
      Review
    3. ID
      63283
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202_125261-ustekinumab-clinical-prea.pdf
      Date
      19000101
      Type
      Pediatric Medical Review
    4. ID
      24358
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125261s000_SumR.pdf
      Date
      20100122
      Type
      Summary Review
    5. ID
      31870
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125261s000ltr.pdf
      Date
      20091005
      Type
      Letter
  5. Submission type
    SUPPL
    Submission number
    129
    Submission status
    AP
    Submission status date
    20170215
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      48148
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125261Orig1s129ltr.pdf
      Date
      20170427
      Type
      Letter
  6. Submission type
    SUPPL
    Submission number
    13
    Submission status
    AP
    Submission status date
    20101020
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      39879
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125261s0013lbl.pdf
      Date
      20120409
      Type
      Label
    2. ID
      9651
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125261s013ltr.pdf
      Date
      20101228
      Type
      Letter
  7. Submission type
    SUPPL
    Submission number
    58
    Submission status
    AP
    Submission status date
    20120406
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      31872
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125261s0058ltr.pdf
      Date
      20120411
      Type
      Letter
  8. Submission type
    SUPPL
    Submission number
    141
    Submission status
    AP
    Submission status date
    20180216
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      52685
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125261s141lbl.pdf
      Date
      20180222
      Type
      Label
    2. ID
      52700
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125261Orig1s141ltr.pdf
      Date
      20180223
      Type
      Letter
  9. Submission type
    SUPPL
    Submission number
    99
    Submission status
    AP
    Submission status date
    20130429
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      9654
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125261Orig1s099ltr.pdf
      Date
      20130501
      Type
      Letter
    2. ID
      18826
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125261s099lbl.pdf
      Date
      20130501
      Type
      Label
  10. Submission type
    SUPPL
    Submission number
    168
    Submission status
    AP
    Submission status date
    20250401
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      81809
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125261Orig1s168, 761044Orig1s016lbl.pdf
      Date
      20250402
      Type
      Label
    2. ID
      81870
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125261Orig1s168, 761044Orig1s016ltr.pdf
      Date
      20250408
      Type
      Letter
  11. Submission type
    SUPPL
    Submission number
    174
    Submission status
    AP
    Submission status date
    20260715
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      86584
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125261Orig1s174ltr.pdf
      Date
      20260716
      Type
      Letter
    2. ID
      86732
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125261s174lbl.pdf
      Date
      20260729
      Type
      Label
    3. ID
      86733
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125261s174lbl.pdf#page=39
      Date
      20260729
      Type
      Medication Guide
  12. Submission type
    SUPPL
    Submission number
    166
    Submission status
    AP
    Submission status date
    20241115
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      80228
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125261s166,761044s014lbl.pdf
      Date
      20241118
      Type
      Label
    2. ID
      80239
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125261Orig1s166, 761044Orig1s014ltr.pdf
      Date
      20241119
      Type
      Letter
  13. +20 more not shown
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    STELARA
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      USTEKINUMAB
      Strength
      45MG/0.5ML
  2. Product number
    002
    Reference drug
    No
    Brand name
    STELARA
    Dosage form
    INJECTABLE
    Route
    INJECTION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      USTEKINUMAB
      Strength
      90MG/1ML
Harmonized identifiers (openFDA)
Application number
BLA125261
Brand name
STELARA
Generic name
USTEKINUMAB
Manufacturer name
Janssen Biotech, Inc.
Product NDC
57894-060, 57894-061, 57894-054
Product type
HUMAN PRESCRIPTION DRUG
Route
SUBCUTANEOUS
Substance name
USTEKINUMAB
RxCUI
853350, 853354, 853355, 853356, 1654077, 1654079, 1811255, 1811257
SPL ID
30a2caf3-0c87-47a6-b087-25028ff6f8c0
SPL set ID
c77a9664-e3bb-4023-b400-127aa53bca2b
Package NDC
57894-061-02, 57894-061-03, 57894-061-04, 57894-054-27, 57894-054-16, 57894-060-02, 57894-060-03, 57894-060-04
Nui
N0000192797, N0000192796, N0000192799, N0000192798
Pharm class epc
Interleukin-12 Antagonist [EPC], Interleukin-23 Antagonist [EPC]
Pharm class moa
Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonists [MoA]
UNII
FU77B4U5Z0
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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.