{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "20190626",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "59187",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210238Orig1s001ltr.pdf",
              "date": "20190620",
              "type": "Letter"
            },
            {
              "id": "59193",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210238s001lbl.pdf",
              "date": "20190628",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20211014",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68999",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210238s006lbl.pdf",
              "date": "20211015",
              "type": "Label"
            },
            {
              "id": "69024",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210238Orig1s006ltr.pdf",
              "date": "20211019",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20200820",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64345",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210238s004lbl.pdf",
              "date": "20200821",
              "type": "Label"
            },
            {
              "id": "64378",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210238Orig1s004ltr.pdf",
              "date": "20200824",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20190321",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58066",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210238s002lbl.pdf",
              "date": "20190322",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20250724",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "82941",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210238Orig1s010ltr.pdf",
              "date": "20250725",
              "type": "Letter"
            },
            {
              "id": "82962",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210238Orig1s010lbl.pdf",
              "date": "20260512",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20240718",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "79130",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210238Orig1s009ltr.pdf",
              "date": "20240722",
              "type": "Letter"
            },
            {
              "id": "79147",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210238s009lbl.pdf",
              "date": "20240722",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20180521",
          "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": "54258",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210238s000lbl.pdf",
              "date": "20180521",
              "type": "Label"
            },
            {
              "id": "54319",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210238Orig1s000ltr.pdf",
              "date": "20180524",
              "type": "Letter"
            },
            {
              "id": "54724",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210238Orig1s000TOC.html",
              "date": "20180628",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA210238",
      "sponsor_name": "AKARX INC",
      "openfda": {
        "application_number": [
          "NDA210238"
        ],
        "brand_name": [
          "DOPTELET"
        ],
        "generic_name": [
          "AVATROMBOPAG MALEATE"
        ],
        "manufacturer_name": [
          "AkaRx, Inc."
        ],
        "product_ndc": [
          "71369-020",
          "71369-010"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "AVATROMBOPAG MALEATE"
        ],
        "rxcui": [
          "2045951",
          "2045952",
          "2045958",
          "2045959",
          "2045960",
          "2045961",
          "2721188",
          "2721192"
        ],
        "spl_id": [
          "4d4d84be-34cd-4027-b69a-2f16ec5049ed"
        ],
        "spl_set_id": [
          "e2d5960d-6c18-46cc-86bd-089222b09852"
        ],
        "package_ndc": [
          "71369-020-11",
          "71369-020-10",
          "71369-020-16",
          "71369-020-15",
          "71369-020-30",
          "71369-010-30"
        ],
        "unii": [
          "GDW7M2P1IS"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "DOPTELET",
          "active_ingredients": [
            {
              "name": "AVATROMBOPAG MALEATE",
              "strength": "EQ 20MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}