{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20180419",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "53751",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021313s010,021605s013lbl.pdf",
              "date": "20180420",
              "type": "Label"
            },
            {
              "id": "53781",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021313Orig1s010,021605Orig1s013ltr.pdf",
              "date": "20180423",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20091230",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5834",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021605s006ltr.pdf",
              "date": "20100105",
              "type": "Letter"
            },
            {
              "id": "37329",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021605s006lbl.pdf",
              "date": "20100112",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20140307",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5835",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021605Orig1s012ltr.pdf",
              "date": "20140310",
              "type": "Letter"
            },
            {
              "id": "15862",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021605s012lbl.pdf",
              "date": "20140310",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20050303",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "37328",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021605lbl.pdf",
              "date": "20050310",
              "type": "Label"
            },
            {
              "id": "42230",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021605s000TOC.html",
              "date": "20070509",
              "type": "Review"
            },
            {
              "id": "5833",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021605ltr.pdf",
              "date": "20050310",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20190315",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58018",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021165Orig1s022, 021300Orig1s019, 021312Orig1s020, 021563Orig1s008, 021313Orig1s012, 021605Orig1s017ltr.pdf",
              "date": "20190318",
              "type": "Letter"
            },
            {
              "id": "58024",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021605s017lbl.pdf",
              "date": "20190318",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20180228",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "52787",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021605Orig1s015ltr.pdf",
              "date": "20180301",
              "type": "Letter"
            },
            {
              "id": "52818",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021605s015lbl.pdf",
              "date": "20180306",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA021605",
      "sponsor_name": "ORGANON",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CLARINEX D 24 HOUR",
          "active_ingredients": [
            {
              "name": "DESLORATADINE",
              "strength": "5MG"
            },
            {
              "name": "PSEUDOEPHEDRINE SULFATE",
              "strength": "240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}