{
  "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": "2",
          "submission_status": "AP",
          "submission_status_date": "19970502",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20260320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "85442",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/020500Orig1s020ltr.pdf",
              "date": "20260323",
              "type": "Letter"
            },
            {
              "id": "85637",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020500s020lbl.pdf",
              "date": "20260406",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20080507",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2607",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020500s010ltr.pdf",
              "date": "20080509",
              "type": "Letter"
            },
            {
              "id": "34717",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020500s010lbl.pdf",
              "date": "20080512",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19950208",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20190718",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "59378",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020500s019lbl.pdf",
              "date": "20190719",
              "type": "Label"
            },
            {
              "id": "59384",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020500Orig1s019ltr.pdf",
              "date": "20190719",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20190222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57816",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020500Orig1s017ltr.pdf",
              "date": "20190227",
              "type": "Letter"
            },
            {
              "id": "57879",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020500s017lbl.pdf",
              "date": "20190304",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "19990105",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "41397",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020500S005.html",
              "date": "20040609",
              "type": "Review"
            },
            {
              "id": "12642",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20-500-S005.PDF",
              "date": "20040609",
              "type": "Label"
            },
            {
              "id": "25054",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20500s5ltr.pdf",
              "date": "20040609",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20150604",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12644",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020500s015lbl.pdf",
              "date": "20150610",
              "type": "Label"
            },
            {
              "id": "2608",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020500Orig1s015ltr.pdf",
              "date": "20150610",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19970812",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19950428",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20171015",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50070",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/20500s016lbl.pdf",
              "date": "20171017",
              "type": "Label"
            },
            {
              "id": "50087",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020500Orig1s016ltr.pdf",
              "date": "20171018",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19980914",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20130301",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12643",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020500s014lbl.pdf",
              "date": "20130305",
              "type": "Label"
            },
            {
              "id": "25055",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020500Orig1s014ltr.pdf",
              "date": "20130304",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA020500",
      "sponsor_name": "GLAXOSMITHKLINE LLC",
      "openfda": {
        "application_number": [
          "NDA020500"
        ],
        "brand_name": [
          "MEPRON"
        ],
        "generic_name": [
          "ATOVAQUONE"
        ],
        "manufacturer_name": [
          "GlaxoSmithKline LLC"
        ],
        "product_ndc": [
          "0173-0547",
          "0173-0665"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ATOVAQUONE"
        ],
        "rxcui": [
          "211947",
          "308429"
        ],
        "spl_id": [
          "005bf875-7785-4b73-8c03-fa75737de8a9"
        ],
        "spl_set_id": [
          "b426b6bf-f07e-4580-97ae-dfca1ddf5b8f"
        ],
        "package_ndc": [
          "0173-0665-18",
          "0173-0547-00"
        ],
        "nui": [
          "N0000175482",
          "N0000175485"
        ],
        "pharm_class_epc": [
          "Antimalarial [EPC]",
          "Antiprotozoal [EPC]"
        ],
        "unii": [
          "Y883P1Z2LT"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "MEPRON",
          "active_ingredients": [
            {
              "name": "ATOVAQUONE",
              "strength": "750MG/5ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SUSPENSION",
          "route": "ORAL",
          "marketing_status": "Prescription",
          "te_code": "AB"
        }
      ]
    }
  ]
}