{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20040721",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "42193",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-497_21-498s001_Alinia.html",
              "date": "20041008",
              "type": "Review"
            },
            {
              "id": "5544",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21497,21498s001ltr.pdf",
              "date": "20040721",
              "type": "Letter"
            },
            {
              "id": "15600",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf",
              "date": "20040721",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20121205",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20211216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "submission_property_type": [
            {
              "code": "Orphan"
            }
          ],
          "application_docs": [
            {
              "id": "69620",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021497s017lbl.pdf",
              "date": "20211217",
              "type": "Label"
            },
            {
              "id": "69700",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021497Orig1s017ltr.pdf",
              "date": "20211221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160711",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "15601",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf",
              "date": "20160713",
              "type": "Label"
            },
            {
              "id": "27932",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021497Orig1s001,021498Orig1s004ltr.pdf",
              "date": "20160712",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20150303",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20220119",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69933",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021497s018,021498s019lbl.pdf",
              "date": "20220120",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA021497",
      "sponsor_name": "ROMARK",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ALINIA",
          "active_ingredients": [
            {
              "name": "NITAZOXANIDE",
              "strength": "500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued",
          "te_code": "AB"
        }
      ]
    }
  ]
}