Approvals (Drugs@FDA)

ORENCIA

BRISTOL MYERS SQUIBB · ABATACEPT

BLA125118Biologic (BLA)Prescription
Open FDA's page for this record
Application number
BLA125118
Sponsor name
BRISTOL MYERS SQUIBB
Submissions
  1. Submission type
    SUPPL
    Submission number
    131
    Submission status
    AP
    Submission status date
    20110818
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
  2. Submission type
    SUPPL
    Submission number
    249
    Submission status
    AP
    Submission status date
    20240119
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      77268
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125118Orig1s249ltr.pdf
      Date
      20240123
      Type
      Letter
    2. ID
      77274
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125118s249lbl.pdf
      Date
      20240123
      Type
      Label
  3. Submission type
    SUPPL
    Submission number
    107
    Submission status
    AP
    Submission status date
    20110623
    Submission class code
    MANUF (CMC)
    Submission class code description
    Manufacturing (CMC)
    Application docs
    1. ID
      22787
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/125118Orig1s107.pdf
      Date
      20140117
      Type
      Review
  4. Submission type
    SUPPL
    Submission number
    255
    Submission status
    AP
    Submission status date
    20240529
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      78579
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125118Orig1s255ltr.pdf
      Date
      20240530
      Type
      Letter
    2. ID
      78603
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125118s255lbl.pdf
      Date
      20240531
      Type
      Label
  5. Submission type
    SUPPL
    Submission number
    45
    Submission status
    AP
    Submission status date
    20080407
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      51937
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/012510125118s045_Abatacept_Statistical_PREA.pdf
      Date
      19000101
      Type
      Pediatric Statistical Review
    2. ID
      63845
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/B125118_abatacept_Orig_WR.pdf
      Date
      19000101
      Type
      Pediatric Written Request
    3. ID
      9614
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125118s045ltr.pdf
      Date
      20080603
      Type
      Letter
  6. Submission type
    SUPPL
    Submission number
    200
    Submission status
    AP
    Submission status date
    20160607
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
  7. Submission type
    SUPPL
    Submission number
    235
    Submission status
    AP
    Submission status date
    20220413
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      70767
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125118Orig1s235ltr.pdf
      Date
      20220415
      Type
      Letter
  8. Submission type
    SUPPL
    Submission number
    86
    Submission status
    AP
    Submission status date
    20090825
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      39850
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf
      Date
      20090827
      Type
      Label
    2. ID
      31838
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125118s0086ltr.pdf
      Date
      20090901
      Type
      Letter
  9. Submission type
    SUPPL
    Submission number
    199
    Submission status
    AP
    Submission status date
    20200617
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      63630
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125118s194,s199,s225lbl.pdf
      Date
      20200619
      Type
      Label
    2. ID
      63648
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125118Origs194, s199, s225ltr.pdf
      Date
      20200622
      Type
      Letter
  10. Submission type
    SUPPL
    Submission number
    138
    Submission status
    AP
    Submission status date
    20120217
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      39851
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125118s0138lbl.pdf
      Date
      20120222
      Type
      Label
    2. ID
      31840
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125118s0138ltr.pdf
      Date
      20120223
      Type
      Letter
  11. Submission type
    SUPPL
    Submission number
    225
    Submission status
    AP
    Submission status date
    20200617
    Review priority
    STANDARD
    Submission class code
    LABELING
    Submission class code description
    Labeling
    Application docs
    1. ID
      63631
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125118s194,s199,s225lbl.pdf
      Date
      20200619
      Type
      Label
    2. ID
      63649
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125118Origs194, s199, s225ltr.pdf
      Date
      20200622
      Type
      Letter
  12. Submission type
    SUPPL
    Submission number
    209
    Submission status
    AP
    Submission status date
    20170630
    Review priority
    STANDARD
    Submission class code
    EFFICACY
    Submission class code description
    Efficacy
    Application docs
    1. ID
      48889
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s209lbl.pdf
      Date
      20170703
      Type
      Label
    2. ID
      48902
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125118Orig1s209ltr.pdf
      Date
      20170705
      Type
      Letter
  13. +12 more not shown
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    ORENCIA
    Dosage form
    INJECTABLE
    Route
    IV (INFUSION)
    Marketing status
    Prescription
    Active ingredients
    1. Name
      ABATACEPT
      Strength
      250MG
Harmonized identifiers (openFDA)
Application number
BLA125118
Brand name
ORENCIA
Generic name
ABATACEPT
Manufacturer name
E.R. Squibb & Sons, L.L.C.
Product NDC
0003-2814, 0003-2187, 0003-2188, 0003-2818
Product type
HUMAN PRESCRIPTION DRUG
Route
SUBCUTANEOUS, INTRAVENOUS
Substance name
ABATACEPT
RxCUI
616015, 616018, 1145929, 1145932, 1799228, 1799230, 1925254, 1925255, 1925256, 1925257
SPL ID
962695b7-21f5-44bb-80e0-cb3b48c80be6
SPL set ID
0836c6ac-ee37-5640-2fed-a3185a0b16eb
Package NDC
0003-2187-10, 0003-2187-13, 0003-2188-11, 0003-2188-21, 0003-2188-91, 0003-2188-51, 0003-2188-50, 0003-2188-90, 0003-2814-11, 0003-2818-11
Nui
N0000008571, N0000182159, M0018640
Pharm class pe
Decreased Cytokine Activity [PE]
Pharm class epc
Selective T Cell Costimulation Modulator [EPC]
Pharm class cs
Recombinant Fusion Proteins [CS]
UNII
7D0YB67S97
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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.