{
  "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": "7",
          "submission_status": "AP",
          "submission_status_date": "20190411",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "58310",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s007lbl.pdf",
              "date": "20190412",
              "type": "Label"
            },
            {
              "id": "58335",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203255Orig1s007ltr.pdf",
              "date": "20190415",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20190129",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "57384",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203255s005lbl.pdf",
              "date": "20190130",
              "type": "Label"
            },
            {
              "id": "57579",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200677Orig1s004, 203255Orig1s005ltr.pdf",
              "date": "20190213",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20150708",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20200709",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "63840",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203255s008lbl.pdf",
              "date": "20200710",
              "type": "Label"
            },
            {
              "id": "63843",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203255Orig1s008ltr.pdf",
              "date": "20200710",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20141215",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "40282",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203255s000lbl.pdf",
              "date": "20141216",
              "type": "Label"
            },
            {
              "id": "10193",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203255Orig1s000ltr.pdf",
              "date": "20141216",
              "type": "Letter"
            },
            {
              "id": "22918",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000TOC.html",
              "date": "20160302",
              "type": "Review"
            },
            {
              "id": "24430",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203255Orig1s000SumR.pdf",
              "date": "20160302",
              "type": "Summary Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20180629",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "54764",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s004lbl.pdf",
              "date": "20180705",
              "type": "Label"
            },
            {
              "id": "54822",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203255Orig1s004ltr.pdf",
              "date": "20180706",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20240711",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "79067",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203255Orig1s011ltr.pdf",
              "date": "20240715",
              "type": "Letter"
            },
            {
              "id": "79090",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203255s011lbl.pdf",
              "date": "20240715",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20180309",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "52933",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203255s002lbl.pdf",
              "date": "20180313",
              "type": "Label"
            },
            {
              "id": "52991",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200677Orig1s003,203255Orig1s002ltr.pdf",
              "date": "20180315",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA203255",
      "sponsor_name": "RECORDATI RARE",
      "openfda": {
        "application_number": [
          "NDA203255"
        ],
        "brand_name": [
          "SIGNIFOR LAR"
        ],
        "generic_name": [
          "PASIREOTIDE"
        ],
        "manufacturer_name": [
          "Recordati Rare Diseases, Inc."
        ],
        "product_ndc": [
          "55292-139",
          "55292-140",
          "55292-141",
          "55292-142",
          "55292-143"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "1597596",
          "1597599",
          "1597601",
          "1597603",
          "1597820",
          "1597822",
          "2049730",
          "2049732",
          "2049734",
          "2049736"
        ],
        "spl_id": [
          "fb5687ef-6bbc-4ac4-899e-46c941f214c5"
        ],
        "spl_set_id": [
          "a0aad470-3f38-af97-e053-2995a90a383a"
        ],
        "package_ndc": [
          "55292-139-01",
          "55292-134-01",
          "55292-140-01",
          "55292-135-01",
          "55292-141-01",
          "55292-136-01",
          "55292-142-01",
          "55292-137-01",
          "55292-143-01",
          "55292-138-01"
        ]
      },
      "products": [
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "SIGNIFOR LAR KIT",
          "active_ingredients": [
            {
              "name": "PASIREOTIDE PAMOATE",
              "strength": "EQ 10MG BASE/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "SIGNIFOR LAR KIT",
          "active_ingredients": [
            {
              "name": "PASIREOTIDE PAMOATE",
              "strength": "EQ 40MG BASE/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "SIGNIFOR LAR KIT",
          "active_ingredients": [
            {
              "name": "PASIREOTIDE PAMOATE",
              "strength": "EQ 30MG BASE/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "SIGNIFOR LAR KIT",
          "active_ingredients": [
            {
              "name": "PASIREOTIDE PAMOATE",
              "strength": "EQ 60MG BASE/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "FOR SUSPENSION",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "SIGNIFOR LAR KIT",
          "active_ingredients": [
            {
              "name": "PASIREOTIDE PAMOATE",
              "strength": "EQ 20MG BASE/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FOR SUSPENSION",
          "route": "INTRAMUSCULAR",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}