{
  "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": "4",
          "submission_status": "AP",
          "submission_status_date": "20200319",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "62209",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210656s002s004lbl.pdf",
              "date": "20200320",
              "type": "Label"
            },
            {
              "id": "62214",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210656Orig1s002,s004ltr.pdf",
              "date": "20200320",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20200319",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "62210",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210656s002s004lbl.pdf",
              "date": "20200320",
              "type": "Label"
            },
            {
              "id": "62215",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210656Orig1s002,s004ltr.pdf",
              "date": "20200320",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20230327",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "73887",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210656Orig1s005ltr.pdf",
              "date": "20230328",
              "type": "Letter"
            },
            {
              "id": "73895",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210656s005lbl.pdf",
              "date": "20230328",
              "type": "Label"
            },
            {
              "id": "73896",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210656s005lbl.pdf#page=20",
              "date": "20230328",
              "type": "Medication Guide"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20181121",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "56533",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210656s000lbl.pdf",
              "date": "20181121",
              "type": "Label"
            },
            {
              "id": "56700",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210656Orig1s000ltr.pdf",
              "date": "20181210",
              "type": "Letter"
            },
            {
              "id": "56753",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210656Orig1s000TOC.html",
              "date": "20181217",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA210656",
      "sponsor_name": "PFIZER",
      "openfda": {
        "application_number": [
          "NDA210656"
        ],
        "brand_name": [
          "DAURISMO"
        ],
        "generic_name": [
          "GLASDEGIB"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "0069-0298",
          "0069-1531"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "GLASDEGIB"
        ],
        "rxcui": [
          "2105850",
          "2105856",
          "2105858",
          "2105860"
        ],
        "spl_id": [
          "e850e390-b32e-4382-a2c7-d480c41bd3a6"
        ],
        "spl_set_id": [
          "204a6f7e-c9a4-472b-abd2-9527bda64d17"
        ],
        "package_ndc": [
          "0069-0298-60",
          "0069-1531-30"
        ],
        "nui": [
          "N0000184149",
          "N0000184148"
        ],
        "pharm_class_epc": [
          "Hedgehog Pathway Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Smoothened Receptor Antagonists [MoA]"
        ],
        "unii": [
          "K673DMO5H9"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "DAURISMO",
          "active_ingredients": [
            {
              "name": "GLASDEGIB MALEATE",
              "strength": "EQ 100MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "DAURISMO",
          "active_ingredients": [
            {
              "name": "GLASDEGIB MALEATE",
              "strength": "EQ 25MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}