{
  "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": "11",
          "submission_status": "AP",
          "submission_status_date": "20171221",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20011024",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20451",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020021_S006_SUDAFED_AP.pdf",
              "date": "20070706",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19980805",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20450",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/020021_S004_EFIDAC_AP.pdf",
              "date": "20070706",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19930521",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20449",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20021_S002_EFIDAC 24_AP.pdf",
              "date": "20070509",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20181113",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56482",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020021Orig1s012lbl.pdf",
              "date": "20181123",
              "type": "Label"
            },
            {
              "id": "56680",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020021Orig1s012ltr.pdf",
              "date": "20181207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19921215",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20010328",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "41121",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020021_S005_SUDAFED_AP.pdf",
              "date": "20070706",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19950509",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "41120",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20021_S003_EFIDAC 24_AP.pdf",
              "date": "20070509",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19930201",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "20448",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/20021_S001_EFIDAC 24_AP.pdf",
              "date": "20070509",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA020021",
      "sponsor_name": "KENVUE BRANDS",
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "SUDAFED 24 HOUR",
          "active_ingredients": [
            {
              "name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
              "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"
        }
      ]
    }
  ]
}