{
  "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": "12",
          "submission_status": "AP",
          "submission_status_date": "20230907",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "75369",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209936s012lbl.pdf",
              "date": "20230907",
              "type": "Label"
            },
            {
              "id": "75375",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209936Orig1s012ltr.pdf",
              "date": "20230908",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20220223",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "70241",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209936Orig1s010ltr.pdf",
              "date": "20220224",
              "type": "Letter"
            },
            {
              "id": "70258",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209936s010lbl.pdf",
              "date": "20220225",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20210517",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20200212",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61878",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209936s004lbl.pdf",
              "date": "20200213",
              "type": "Label"
            },
            {
              "id": "61885",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209936Orig1s004ltr.pdf",
              "date": "20200213",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20190524",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "58872",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209936s002lbl.pdf",
              "date": "20190529",
              "type": "Label"
            },
            {
              "id": "58937",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209936Orig1s002ltr.pdf",
              "date": "20190604",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20230330",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "73911",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209936Orig1s011ltr.pdf",
              "date": "20230331",
              "type": "Letter"
            },
            {
              "id": "73915",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209936s011lbl.pdf",
              "date": "20230331",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20191028",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60698",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209936s003lbl.pdf",
              "date": "20191029",
              "type": "Label"
            },
            {
              "id": "60706",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209936Orig1s003ltr.pdf",
              "date": "20191029",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170914",
          "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": "49730",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209936s000lbl.pdf",
              "date": "20170914",
              "type": "Label"
            },
            {
              "id": "49731",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209936Orig1s000Ltr.pdf",
              "date": "20170914",
              "type": "Letter"
            },
            {
              "id": "50061",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209936Orig1_toc.html",
              "date": "20171016",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA209936",
      "sponsor_name": "BAYER HEALTHCARE",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ALIQOPA",
          "active_ingredients": [
            {
              "name": "COPANLISIB DIHYDROCHLORIDE",
              "strength": "60MG/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "POWDER",
          "route": "INTRAVENOUS",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}