{
  "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": "25",
          "submission_status": "AP",
          "submission_status_date": "20230323",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73839",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204242s025lbl.pdf",
              "date": "20230324",
              "type": "Label"
            },
            {
              "id": "73854",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204242Orig1s025ltr.pdf",
              "date": "20230324",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20141211",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "10312",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204242Orig1s003ltr.pdf",
              "date": "20141212",
              "type": "Letter"
            },
            {
              "id": "19535",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204242s003lbl.pdf",
              "date": "20150203",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20191007",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60460",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204242Orig1s017ltr.pdf",
              "date": "20191009",
              "type": "Letter"
            },
            {
              "id": "60477",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204242s017lbl.pdf",
              "date": "20191009",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20250519",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "82212",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204242Orig1s031ltr.pdf",
              "date": "20250521",
              "type": "Letter"
            },
            {
              "id": "82237",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204242s031lbl.pdf",
              "date": "20250519",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20140114",
          "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": "20220617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71374",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204242Orig1s021, s023ltr.pdf",
              "date": "20220621",
              "type": "Letter"
            },
            {
              "id": "71395",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204242s021s023lbl.pdf",
              "date": "20220621",
              "type": "Label"
            },
            {
              "id": "71397",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204242s021s023lbl.pdf#page=20",
              "date": "20220621",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20181031",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "56297",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204242Orig1s015ltr.pdf",
              "date": "20181106",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20220617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71373",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204242Orig1s021, s023ltr.pdf",
              "date": "20220621",
              "type": "Letter"
            },
            {
              "id": "71396",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204242s021s023lbl.pdf",
              "date": "20220621",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20170908",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49708",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204242s011lbl.pdf",
              "date": "20170911",
              "type": "Label"
            },
            {
              "id": "49709",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204242Orig1s011ltr.pdf",
              "date": "20170911",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20160707",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "32530",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s008ltr.pdf",
              "date": "20160712",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20150604",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "19536",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s006lbl.pdf",
              "date": "20150610",
              "type": "Label"
            },
            {
              "id": "32529",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s006ltr.pdf",
              "date": "20150610",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20240320",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "77895",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204242Orig1s026ltr.pdf",
              "date": "20240321",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20150810",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "40367",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204242s004lbl.pdf",
              "date": "20150811",
              "type": "Label"
            },
            {
              "id": "32527",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s004ltr.pdf",
              "date": "20150811",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20251222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "84577",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204242Orig1s032ltr.pdf",
              "date": "20251229",
              "type": "Letter"
            },
            {
              "id": "84658",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204242s032lbl.pdf",
              "date": "20260106",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20130904",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "32526",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s002ltr.pdf",
              "date": "20130909",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20221216",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "73065",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204242Orig1s024ltr.pdf",
              "date": "20221229",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20220503",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "70974",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204242Orig1s022ltr.pdf",
              "date": "20220504",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20180201",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "52244",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204242s014lbl.pdf",
              "date": "20180201",
              "type": "Label"
            },
            {
              "id": "52289",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204242Orig1s014ltr.pdf",
              "date": "20180202",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20170523",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "48521",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204242Orig1s012ltr.pdf",
              "date": "20170525",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130703",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "40366",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204242s000lbl.pdf",
              "date": "20130705",
              "type": "Label"
            },
            {
              "id": "43459",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204242Orig1s000TOC.html",
              "date": "20140627",
              "type": "Review"
            },
            {
              "id": "44591",
              "title": "REMS",
              "url": "http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9",
              "date": "20130723",
              "type": "Other"
            },
            {
              "id": "10311",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204242Orig1s000ltr.pdf",
              "date": "20130708",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20161216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "46433",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s009ltr.pdf",
              "date": "20161221",
              "type": "Letter"
            },
            {
              "id": "46436",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s009lbl.pdf",
              "date": "20161221",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20250221",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "81361",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204242Orig1s029ltr.pdf",
              "date": "20250225",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20161004",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "45505",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204242Orig1s007ltr.pdf",
              "date": "20161006",
              "type": "Letter"
            },
            {
              "id": "45598",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204242s007lbl.pdf",
              "date": "20161007",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20231215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "76966",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204242s027lbl.pdf",
              "date": "20231218",
              "type": "Label"
            },
            {
              "id": "76967",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204242s027lbl.pdf#page=19",
              "date": "20231218",
              "type": "Medication Guide"
            },
            {
              "id": "77075",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204242Orig1s027ltr.pdf",
              "date": "20231219",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20150212",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "32528",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204242Orig1s005ltr.pdf",
              "date": "20150217",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20210304",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "66610",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204242Orig1s019ltr.pdf",
              "date": "20210308",
              "type": "Letter"
            },
            {
              "id": "66644",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204242s019lbl.pdf",
              "date": "20210308",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA204242",
      "sponsor_name": "EDENBRIDGE PHARMS",
      "openfda": {
        "application_number": [
          "NDA204242"
        ],
        "brand_name": [
          "ZUBSOLV"
        ],
        "generic_name": [
          "BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Orexo US, Inc."
        ],
        "product_ndc": [
          "54123-114",
          "54123-907",
          "54123-914",
          "54123-929",
          "54123-957",
          "54123-986"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBLINGUAL"
        ],
        "substance_name": [
          "BUPRENORPHINE HYDROCHLORIDE",
          "NALOXONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1431076",
          "1431083",
          "1431102",
          "1431104",
          "1597568",
          "1597570",
          "1597573",
          "1597575",
          "1666338",
          "1666385",
          "1864412",
          "1864414"
        ],
        "spl_id": [
          "8c67e97f-118f-4226-972a-a9031ef6f5ce"
        ],
        "spl_set_id": [
          "5f5cfcfe-d52b-49e6-8fe4-550477332dd2"
        ],
        "package_ndc": [
          "54123-907-30",
          "54123-914-30",
          "54123-929-30",
          "54123-957-30",
          "54123-986-30",
          "54123-114-30"
        ],
        "unii": [
          "56W8MW3EN1",
          "F850569PQR"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ZUBSOLV",
          "active_ingredients": [
            {
              "name": "BUPRENORPHINE HYDROCHLORIDE",
              "strength": "EQ 1.4MG BASE"
            },
            {
              "name": "NALOXONE HYDROCHLORIDE",
              "strength": "EQ 0.36MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "SUBLINGUAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "ZUBSOLV",
          "active_ingredients": [
            {
              "name": "BUPRENORPHINE HYDROCHLORIDE",
              "strength": "EQ 0.7MG BASE"
            },
            {
              "name": "NALOXONE HYDROCHLORIDE",
              "strength": "EQ 0.18MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "SUBLINGUAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "ZUBSOLV",
          "active_ingredients": [
            {
              "name": "BUPRENORPHINE HYDROCHLORIDE",
              "strength": "EQ 11.4MG BASE"
            },
            {
              "name": "NALOXONE HYDROCHLORIDE",
              "strength": "EQ 2.9MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "SUBLINGUAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "ZUBSOLV",
          "active_ingredients": [
            {
              "name": "BUPRENORPHINE HYDROCHLORIDE",
              "strength": "EQ 5.7MG BASE"
            },
            {
              "name": "NALOXONE HYDROCHLORIDE",
              "strength": "EQ 1.4MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "SUBLINGUAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "ZUBSOLV",
          "active_ingredients": [
            {
              "name": "BUPRENORPHINE HYDROCHLORIDE",
              "strength": "EQ 2.9MG BASE"
            },
            {
              "name": "NALOXONE HYDROCHLORIDE",
              "strength": "EQ 0.71MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "SUBLINGUAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "ZUBSOLV",
          "active_ingredients": [
            {
              "name": "BUPRENORPHINE HYDROCHLORIDE",
              "strength": "EQ 8.6MG BASE"
            },
            {
              "name": "NALOXONE HYDROCHLORIDE",
              "strength": "EQ 2.1MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "SUBLINGUAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}