{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20120829",
          "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": "44891",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203985Orig1s000SumR.pdf",
              "date": "20131112",
              "type": "Summary Review"
            },
            {
              "id": "51097",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203985_Orig1s000MedR_PREA.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "51098",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203985_Everolimus_Clinpharm_BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "51099",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/203985_Everolimus_Statistical_BPCA.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "58107",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/022334_everolimus_Original_WR.pdf",
              "date": "19000101",
              "type": "Pediatric Written Request"
            },
            {
              "id": "10263",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203985Orig1s000ltr.pdf",
              "date": "20120831",
              "type": "Letter"
            },
            {
              "id": "19506",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203985s000lbl.pdf",
              "date": "20120829",
              "type": "Label"
            },
            {
              "id": "22939",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203985_afinitor_toc.html",
              "date": "20131112",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20131106",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "40335",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf",
              "date": "20131108",
              "type": "Label"
            },
            {
              "id": "32486",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022334Orig1s022,203985Orig1s003ltr.pdf",
              "date": "20131107",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130326",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20260601",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "86122",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/203985s028lbl.pdf",
              "date": "20260602",
              "type": "Label"
            },
            {
              "id": "86124",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/022334Orig1s055; 203985Orig1s028ltr.pdf",
              "date": "20260602",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20200213",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "61892",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf",
              "date": "20200214",
              "type": "Label"
            },
            {
              "id": "61897",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022334Orig1s044, 203985Orig1s016ltr.pdf",
              "date": "20200214",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20150123",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "10266",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203985Orig1s008ltr.pdf",
              "date": "20150126",
              "type": "Letter"
            },
            {
              "id": "19509",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203985s008lbl.pdf",
              "date": "20150129",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20210416",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67104",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022334s047,203985s020lbl.pdf",
              "date": "20210419",
              "type": "Label"
            },
            {
              "id": "67111",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022334Orig1s047, 203985Orig1s020ltr.pdf",
              "date": "20210419",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20150701",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20140220",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40336",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf",
              "date": "20140221",
              "type": "Label"
            },
            {
              "id": "10264",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf",
              "date": "20140221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20160129",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "40337",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf",
              "date": "20160202",
              "type": "Label"
            },
            {
              "id": "10267",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s032,203985Orig1s010ltr.pdf",
              "date": "20160201",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20140220",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40334",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf",
              "date": "20140221",
              "type": "Label"
            },
            {
              "id": "32485",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf",
              "date": "20140221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20240311",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "78397",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203985Orig1s027ltr.pdf",
              "date": "20240506",
              "type": "Letter"
            },
            {
              "id": "78399",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203985Orig1s027lbl.pdf",
              "date": "20240506",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20200122",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61625",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022334Orig1s045,203985Orig1s017ltr.pdf",
              "date": "20200123",
              "type": "Letter"
            },
            {
              "id": "61630",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s045,203985s017lbl.pdf",
              "date": "20200123",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20220201",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "70046",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203985Orig1s023; 022334Orig1s051ltr.pdf",
              "date": "20220202",
              "type": "Letter"
            },
            {
              "id": "70062",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203985s023,022334s051lbl.pdf",
              "date": "20220203",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20150824",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20140701",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "10265",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s025,203985Orig1s007ltr.pdf",
              "date": "20140703",
              "type": "Letter"
            },
            {
              "id": "19508",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf",
              "date": "20140702",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20180410",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "53648",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022334s040,203985s013lbl.pdf",
              "date": "20180411",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20140220",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "19507",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf",
              "date": "20140221",
              "type": "Label"
            },
            {
              "id": "32487",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf",
              "date": "20140221",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA203985",
      "sponsor_name": "NOVARTIS PHARM",
      "openfda": {
        "application_number": [
          "NDA203985"
        ],
        "brand_name": [
          "AFINITOR DISPERZ"
        ],
        "generic_name": [
          "EVEROLIMUS"
        ],
        "manufacturer_name": [
          "Novartis Pharmaceuticals Corporation"
        ],
        "product_ndc": [
          "0078-0626",
          "0078-0566",
          "0078-0567",
          "0078-0594",
          "0078-0620",
          "0078-0627",
          "0078-0628"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "EVEROLIMUS"
        ],
        "rxcui": [
          "845507",
          "845512",
          "845515",
          "845518",
          "998189",
          "998191",
          "1119400",
          "1119402",
          "1308428",
          "1308430",
          "1308432",
          "1310138",
          "1310144",
          "1310147"
        ],
        "spl_id": [
          "b808a4e0-23a8-40c8-834d-b31cd642febe"
        ],
        "spl_set_id": [
          "2150f73a-179b-4afc-b8ce-67c85cc72f04"
        ],
        "package_ndc": [
          "0078-0566-61",
          "0078-0566-51",
          "0078-0567-61",
          "0078-0567-51",
          "0078-0594-61",
          "0078-0594-51",
          "0078-0620-61",
          "0078-0620-51",
          "0078-0626-61",
          "0078-0626-51",
          "0078-0627-61",
          "0078-0627-51",
          "0078-0628-61",
          "0078-0628-51"
        ],
        "nui": [
          "N0000175605",
          "N0000175076",
          "N0000182141",
          "N0000182137",
          "N0000175625",
          "N0000175624",
          "N0000175550"
        ],
        "pharm_class_epc": [
          "Kinase Inhibitor [EPC]",
          "mTOR Inhibitor Immunosuppressant [EPC]"
        ],
        "pharm_class_moa": [
          "Protein Kinase Inhibitors [MoA]",
          "Cytochrome P450 3A4 Inhibitors [MoA]",
          "Cytochrome P450 2D6 Inhibitors [MoA]",
          "mTOR Inhibitors [MoA]"
        ],
        "pharm_class_pe": [
          "Decreased Immunologic Activity [PE]"
        ],
        "unii": [
          "9HW64Q8G6G"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "AFINITOR DISPERZ",
          "active_ingredients": [
            {
              "name": "EVEROLIMUS",
              "strength": "3MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "AFINITOR DISPERZ",
          "active_ingredients": [
            {
              "name": "EVEROLIMUS",
              "strength": "5MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET, FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "AFINITOR DISPERZ",
          "active_ingredients": [
            {
              "name": "EVEROLIMUS",
              "strength": "2MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, FOR SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}