{
  "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": "2026-07-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20150312",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6008",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s018ltr.pdf",
              "date": "20150313",
              "type": "Letter"
            },
            {
              "id": "16219",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s018lbl.pdf",
              "date": "20150326",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20160826",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45062",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s024ltr.pdf",
              "date": "20160826",
              "type": "Letter"
            },
            {
              "id": "45115",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf",
              "date": "20160826",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20160321",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37477",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698s022lbl.pdf",
              "date": "20160329",
              "type": "Label"
            },
            {
              "id": "28401",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s022ltr.pdf",
              "date": "20160322",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20151120",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37476",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s020lbl.pdf",
              "date": "20151125",
              "type": "Label"
            },
            {
              "id": "28400",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s020Ltr.pdf",
              "date": "20151123",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20070313",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "28399",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021698s003ltr.pdf",
              "date": "20070315",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20190404",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58242",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021698Orig1s029lbl.pdf",
              "date": "20190408",
              "type": "Label"
            },
            {
              "id": "58243",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021698Orig1s029ltr.pdf",
              "date": "20190408",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20151211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6009",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021698Orig1s019ltr.pdf",
              "date": "20151214",
              "type": "Letter"
            },
            {
              "id": "16220",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021698Orig1s019lbl.pdf",
              "date": "20151222",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20190918",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60050",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021698Orig1s031ltr.pdf",
              "date": "20190919",
              "type": "Letter"
            },
            {
              "id": "60051",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021698Orig1s031lbl.pdf",
              "date": "20190919",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20160727",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45160",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf",
              "date": "20160727",
              "type": "Label"
            },
            {
              "id": "6010",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s023,020520Orig1s033ltr.pdf",
              "date": "20160823",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20040831",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "37475",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21698lbl.pdf",
              "date": "20040903",
              "type": "Label"
            },
            {
              "id": "21782",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021698s000TOC.html",
              "date": "20070604",
              "type": "Review"
            },
            {
              "id": "28398",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21698ltr.pdf",
              "date": "20040903",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20121207",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA021698",
      "sponsor_name": "CHATTEM SANOFI",
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "ZANTAC 150",
          "active_ingredients": [
            {
              "name": "RANITIDINE HYDROCHLORIDE",
              "strength": "EQ 150MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ZANTAC 150",
          "active_ingredients": [
            {
              "name": "RANITIDINE HYDROCHLORIDE",
              "strength": "EQ 150MG BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}