{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "20180305",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "52851",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209819s001lbl.pdf",
              "date": "20180308",
              "type": "Label"
            },
            {
              "id": "52999",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209819Orig1s001ltr.pdf",
              "date": "20180315",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20171130",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "50537",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209819s000lbl.pdf",
              "date": "20171201",
              "type": "Label"
            },
            {
              "id": "50576",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209819Orig1s000ltr.pdf",
              "date": "20171201",
              "type": "Letter"
            },
            {
              "id": "53069",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2017/209819Orig1s000SumR.pdf",
              "date": "20180321",
              "type": "Summary Review"
            },
            {
              "id": "55867",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209819Orig1s000TOC.html",
              "date": "20181011",
              "type": "Review"
            },
            {
              "id": "76280",
              "url": "https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=376",
              "date": "20231103",
              "type": "REMS"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20231215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "76968",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209819s028lbl.pdf",
              "date": "20231218",
              "type": "Label"
            },
            {
              "id": "77059",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209819Orig1s028ltr.pdf",
              "date": "20231219",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20250411",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "81942",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209819Orig1s034ltr.pdf",
              "date": "20250421",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20230912",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "75650",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209819Orig1s026ltr.pdf",
              "date": "20231003",
              "type": "Letter"
            },
            {
              "id": "75658",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209819Orig1s026lbl.pdf",
              "date": "20231003",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20210617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67868",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209819Orig1s018ltr.pdf",
              "date": "20210623",
              "type": "Letter"
            },
            {
              "id": "67877",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s018lbl.pdf",
              "date": "20210623",
              "type": "Label"
            },
            {
              "id": "67878",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s018lbl.pdf#page=45",
              "date": "20210623",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20230703",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "74688",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209819Orig1s024ltr.pdf",
              "date": "20230705",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20200615",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "63585",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209819Orig1s016ltr.pdf",
              "date": "20200617",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20230313",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73743",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209819Orig1s022ltr.pdf",
              "date": "20230314",
              "type": "Letter"
            },
            {
              "id": "73756",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209819s022lbl.pdf",
              "date": "20230314",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20220617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71382",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209819Orig1s020ltr.pdf",
              "date": "20220621",
              "type": "Letter"
            },
            {
              "id": "71411",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209819s020lbl.pdf",
              "date": "20220621",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20200204",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "61780",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209819Orig1s012ltr.pdf",
              "date": "20200205",
              "type": "Letter"
            },
            {
              "id": "61996",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209819s012lbl.pdf",
              "date": "20200228",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20220823",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "71875",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209819Orig1s010ltr.pdf",
              "date": "20220824",
              "type": "Letter"
            },
            {
              "id": "71894",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209819s010lbl.pdf",
              "date": "20220825",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20251222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84584",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209819Orig1s037ltr.pdf",
              "date": "20251229",
              "type": "Letter"
            },
            {
              "id": "84656",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209819s037lbl.pdf",
              "date": "20260106",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20240419",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "78192",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209819Orig1s029ltr.pdf",
              "date": "20240422",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20210922",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "68799",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209819Orig1s019ltr.pdf",
              "date": "20210928",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20210304",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "66535",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s017s018lbl.pdf",
              "date": "20210305",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20250221",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "81338",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209819Orig1s031lbl.pdf",
              "date": "20250930",
              "type": "Label"
            },
            {
              "id": "81339",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209819s031lbl.pdf#page=45",
              "date": "20250224",
              "type": "Medication Guide"
            },
            {
              "id": "83608",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209819Orig1s031ltr.pdf",
              "date": "20250930",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20210511",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67456",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209819s015lbl.pdf",
              "date": "20210512",
              "type": "Label"
            },
            {
              "id": "67469",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209819Orig1s015ltr.pdf",
              "date": "20210512",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20230106",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "73122",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209819Orig1s021ltr.pdf",
              "date": "20230109",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20191007",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "60290",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209819s009lbl.pdf",
              "date": "20191008",
              "type": "Label"
            },
            {
              "id": "60318",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209819Orig1s009ltr.pdf",
              "date": "20191008",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA209819",
      "sponsor_name": "INDIVIOR",
      "openfda": {
        "application_number": [
          "NDA209819"
        ],
        "brand_name": [
          "SUBLOCADE"
        ],
        "generic_name": [
          "BUPRENORPHINE"
        ],
        "manufacturer_name": [
          "Indivior Inc."
        ],
        "product_ndc": [
          "12496-0100",
          "12496-0300"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "BUPRENORPHINE"
        ],
        "rxcui": [
          "1996184",
          "1996189",
          "1996192",
          "1996193"
        ],
        "spl_id": [
          "a5971cb4-0e84-4bc6-a2ff-bbd668f2dbec"
        ],
        "spl_set_id": [
          "6189fb21-9432-45f8-8481-0bfaf3ccde95"
        ],
        "package_ndc": [
          "12496-0100-5",
          "12496-0100-2",
          "12496-0100-1",
          "12496-0300-5",
          "12496-0300-2",
          "12496-0300-1"
        ],
        "nui": [
          "N0000175689",
          "N0000175685"
        ],
        "pharm_class_epc": [
          "Partial Opioid Agonist [EPC]"
        ],
        "pharm_class_moa": [
          "Partial Opioid Agonists [MoA]"
        ],
        "unii": [
          "40D3SCR4GZ"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "SUBLOCADE",
          "active_ingredients": [
            {
              "name": "BUPRENORPHINE",
              "strength": "100MG/0.5ML (100MG/0.5ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION, EXTENDED RELEASE",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "SUBLOCADE",
          "active_ingredients": [
            {
              "name": "BUPRENORPHINE",
              "strength": "300MG/1.5ML (200MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION, EXTENDED RELEASE",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}