{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20160630",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "40342",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf",
              "date": "20160705",
              "type": "Label"
            },
            {
              "id": "10281",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf",
              "date": "20160701",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20151027",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "10279",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s010ltr.pdf",
              "date": "20151028",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130208",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "43452",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000TOC.html",
              "date": "20130320",
              "type": "Review"
            },
            {
              "id": "10272",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s000ltr.pdf",
              "date": "20130211",
              "type": "Letter"
            },
            {
              "id": "19512",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204026lbl.pdf",
              "date": "20130208",
              "type": "Label"
            },
            {
              "id": "24119",
              "title": "REMS",
              "url": "http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=41",
              "date": "20130212",
              "type": "Other"
            },
            {
              "id": "24455",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204026Orig1s000SumR.pdf",
              "date": "20130320",
              "type": "Summary Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20150914",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "10278",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s009ltr.pdf",
              "date": "20150916",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20210805",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "68322",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204026Orig1s029ltr.pdf",
              "date": "20210809",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20260427",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "85784",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/204026Orig1s035ltr.pdf",
              "date": "20260501",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20201120",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "65311",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204026Orig1s027ltr.pdf",
              "date": "20201125",
              "type": "Letter"
            },
            {
              "id": "65314",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s027lbl.pdf",
              "date": "20201125",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20150423",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "40340",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf",
              "date": "20150428",
              "type": "Label"
            },
            {
              "id": "10275",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf",
              "date": "20150424",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20171229",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "50948",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s019ltr.pdf",
              "date": "20171229",
              "type": "Letter"
            },
            {
              "id": "50955",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s019lbl.pdf",
              "date": "20180102",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20140313",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "10274",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s003ltr.pdf",
              "date": "20140319",
              "type": "Letter"
            },
            {
              "id": "19513",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204026s003lbl.pdf",
              "date": "20140319",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20180320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "53256",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204026s017lbl.pdf",
              "date": "20180323",
              "type": "Label"
            },
            {
              "id": "53495",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204026Orig1s017ltr.pdf",
              "date": "20180328",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20230324",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "73869",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204026Orig1s031ltr.pdf",
              "date": "20230327",
              "type": "Letter"
            },
            {
              "id": "73882",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204026s031lbl.pdf",
              "date": "20230327",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20131003",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20200514",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63013",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s023lbl.pdf",
              "date": "20200515",
              "type": "Label"
            },
            {
              "id": "63036",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204026Orig1s023ltr.pdf",
              "date": "20200515",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20191030",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "60751",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204026Orig1s021ltr.pdf",
              "date": "20191031",
              "type": "Letter"
            },
            {
              "id": "60759",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204026s021lbl.pdf",
              "date": "20191031",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20160422",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "10282",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s013ltr.pdf",
              "date": "20160425",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20151201",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "10280",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204026Orig1s011ltr.pdf",
              "date": "20151202",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20150423",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40341",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf",
              "date": "20150428",
              "type": "Label"
            },
            {
              "id": "10277",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf",
              "date": "20150424",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20201203",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "65495",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s028lbl.pdf",
              "date": "20201203",
              "type": "Label"
            },
            {
              "id": "65510",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204026Orig1s028ltr.pdf",
              "date": "20201207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20150423",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "10276",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/0204026Orig1s005,s006,s008ltr.pdf",
              "date": "20150424",
              "type": "Letter"
            },
            {
              "id": "19514",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204026s005s006s008lbl.pdf",
              "date": "20150428",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20250226",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "81376",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204026Orig1s034ltr.pdf",
              "date": "20250227",
              "type": "Letter"
            },
            {
              "id": "81379",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204026s034lbl.pdf",
              "date": "20250227",
              "type": "Label"
            },
            {
              "id": "81380",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204026s034lbl.pdf#page=33",
              "date": "20250227",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20140912",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "32491",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204026Orig1s004ltr.pdf",
              "date": "20140916",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20171130",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "50541",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204026s018lbl.pdf",
              "date": "20171201",
              "type": "Label"
            },
            {
              "id": "50569",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s018ltr.pdf",
              "date": "20171201",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20131115",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "10273",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204026Orig1s002ltr.pdf",
              "date": "20131118",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20200514",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63014",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s024lbl.pdf",
              "date": "20200515",
              "type": "Label"
            },
            {
              "id": "63037",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204026Orig1s024ltr.pdf",
              "date": "20200515",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20170627",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "48866",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204026Orig1s016ltr.pdf",
              "date": "20170629",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20160630",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "40343",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204026s012s014lbl.pdf",
              "date": "20160705",
              "type": "Label"
            },
            {
              "id": "10283",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204026Orig1s012,s014ltr.pdf",
              "date": "20160701",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA204026",
      "sponsor_name": "BRISTOL",
      "openfda": {
        "application_number": [
          "NDA204026"
        ],
        "brand_name": [
          "POMALYST"
        ],
        "generic_name": [
          "POMALIDOMIDE"
        ],
        "manufacturer_name": [
          "Celgene Corporation"
        ],
        "product_ndc": [
          "59572-501",
          "59572-502",
          "59572-503",
          "59572-504"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POMALIDOMIDE"
        ],
        "rxcui": [
          "1369718",
          "1369724",
          "1369726",
          "1369728",
          "1369730",
          "1369732",
          "1369734",
          "1369736"
        ],
        "spl_id": [
          "4410582a-a5f3-429f-a7ca-5c17fb5560bf"
        ],
        "spl_set_id": [
          "2b25ef01-5c9e-11e1-b86c-0800200c9a66"
        ],
        "package_ndc": [
          "59572-501-21",
          "59572-501-00",
          "59572-502-21",
          "59572-502-00",
          "59572-503-21",
          "59572-503-00",
          "59572-504-21",
          "59572-504-00"
        ],
        "nui": [
          "N0000184014"
        ],
        "pharm_class_epc": [
          "Thalidomide Analog [EPC]"
        ],
        "unii": [
          "D2UX06XLB5"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "POMALYST",
          "active_ingredients": [
            {
              "name": "POMALIDOMIDE",
              "strength": "3MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "POMALYST",
          "active_ingredients": [
            {
              "name": "POMALIDOMIDE",
              "strength": "1MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "POMALYST",
          "active_ingredients": [
            {
              "name": "POMALIDOMIDE",
              "strength": "4MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "POMALYST",
          "active_ingredients": [
            {
              "name": "POMALIDOMIDE",
              "strength": "2MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}