{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "5185",
          "submission_status": "AP",
          "submission_status_date": "20140321",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "18629",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103770s5185lbl.pdf",
              "date": "20140325",
              "type": "Label"
            },
            {
              "id": "31637",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103770Orig1s5185ltr.pdf",
              "date": "20140324",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5096",
          "submission_status": "AP",
          "submission_status_date": "20070228",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39690",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103770_5096lbl.pdf",
              "date": "20070307",
              "type": "Label"
            },
            {
              "id": "31636",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103770_5096LTR.pdf",
              "date": "20070306",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5116",
          "submission_status": "AP",
          "submission_status_date": "20090323",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9432",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103770s5116ltr.pdf",
              "date": "20090324",
              "type": "Letter"
            },
            {
              "id": "18627",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103770s5116lbl.pdf",
              "date": "20090324",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5033",
          "submission_status": "AP",
          "submission_status_date": "20030915",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "43280",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/bla/2003/103770Orig1s5033.pdf",
              "date": "20130809",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5161",
          "submission_status": "AP",
          "submission_status_date": "20120404",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "9434",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103770s5161ltr.pdf",
              "date": "20120406",
              "type": "Letter"
            },
            {
              "id": "18628",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103770s5161lbl.pdf",
              "date": "20120406",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19980619",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "22743",
              "url": "https://web.archive.org/web/20160723194308/http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093366.htm",
              "date": "20040329",
              "type": "Review"
            },
            {
              "id": "31634",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/palimed061998L.htm",
              "date": "20040329",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5153",
          "submission_status": "AP",
          "submission_status_date": "20110404",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9433",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103770s5153ltr.pdf",
              "date": "20110517",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5113",
          "submission_status": "AP",
          "submission_status_date": "20080801",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "9431",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103770s5113ltr.pdf",
              "date": "20080805",
              "type": "Letter"
            },
            {
              "id": "18626",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103770s5113lbl.pdf",
              "date": "20081120",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5200",
          "submission_status": "AP",
          "submission_status_date": "20170512",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "48384",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103770s5200lbl.pdf",
              "date": "20170516",
              "type": "Label"
            },
            {
              "id": "48408",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103770Orig1s5200ltr.pdf",
              "date": "20170517",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5022",
          "submission_status": "AP",
          "submission_status_date": "20021023",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement",
          "application_docs": [
            {
              "id": "39688",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/palimed102302LB.pdf",
              "date": "20040329",
              "type": "Label"
            },
            {
              "id": "31635",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/palimed102302L.pdf",
              "date": "20040329",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5059",
          "submission_status": "AP",
          "submission_status_date": "20040723",
          "submission_class_code": "S",
          "submission_class_code_description": "Supplement",
          "application_docs": [
            {
              "id": "39689",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103770_s5059_lbl.pdf",
              "date": "20041222",
              "type": "Label"
            },
            {
              "id": "9430",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103770_s5059_ltr.pdf",
              "date": "20050303",
              "type": "Letter"
            },
            {
              "id": "22744",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/103770Orig1s5059.pdf",
              "date": "20130809",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "BLA103770",
      "sponsor_name": "SWEDISH ORPHAN",
      "openfda": {
        "application_number": [
          "BLA103770"
        ],
        "brand_name": [
          "SYNAGIS"
        ],
        "generic_name": [
          "PALIVIZUMAB"
        ],
        "manufacturer_name": [
          "Swedish Orphan Biovitrum AB (publ)"
        ],
        "product_ndc": [
          "66658-230",
          "66658-231"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "PALIVIZUMAB"
        ],
        "rxcui": [
          "1657341",
          "1657343",
          "1657361",
          "1657362"
        ],
        "spl_id": [
          "48e6af70-cd93-3f1d-e063-6394a90a8104"
        ],
        "spl_set_id": [
          "3a0096c7-8139-44cd-bba4-520ab05c2cb2"
        ],
        "package_ndc": [
          "66658-231-01",
          "66658-230-01"
        ],
        "nui": [
          "M0001357",
          "N0000175615",
          "N0000175623"
        ],
        "pharm_class_cs": [
          "Antibodies, Monoclonal [CS]"
        ],
        "pharm_class_moa": [
          "Fusion Protein Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]"
        ],
        "unii": [
          "DQ448MW7KS"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "SYNAGIS",
          "active_ingredients": [
            {
              "name": "PALIVIZUMAB",
              "strength": "100MG/VIAL"
            }
          ],
          "dosage_form": "VIAL",
          "route": null,
          "marketing_status": "Prescription"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "SYNAGIS",
          "active_ingredients": [
            {
              "name": "PALIVIZUMAB",
              "strength": "50MG/VIAL"
            }
          ],
          "dosage_form": "VIAL",
          "route": null,
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}