{
  "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": "2026-10-30",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20181129",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56602",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021892s014lbl.pdf",
              "date": "20181130",
              "type": "Label"
            },
            {
              "id": "56603",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021892s014lbl.pdf#page=13",
              "date": "20181130",
              "type": "Medication Guide"
            },
            {
              "id": "56820",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021892Orig1s014ltr.pdf",
              "date": "20181220",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20060316",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "37834",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021892s000lbl.pdf",
              "date": "20060322",
              "type": "Label"
            },
            {
              "id": "42341",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021892_osmoprep_toc.html",
              "date": "20080905",
              "type": "Review"
            },
            {
              "id": "28791",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021892s000ltr.pdf",
              "date": "20060323",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20150915",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20121005",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16529",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006lbl.pdf",
              "date": "20121009",
              "type": "Label"
            },
            {
              "id": "23314",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021892s006mg.pdf",
              "date": "20121009",
              "type": "Medication Guide"
            },
            {
              "id": "28794",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021892Orig1s006ltr.pdf",
              "date": "20121010",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20091013",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16528",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021097s014,021892s004lbl.pdf",
              "date": "20091014",
              "type": "Label"
            },
            {
              "id": "28793",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s014,021892s004ltr.pdf",
              "date": "20091125",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20081210",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6398",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021892s002ltr.pdf",
              "date": "20081219",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20160621",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20111209",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "28795",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021892s009,021097s015ltr.pdf",
              "date": "20111214",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20090325",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37835",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021892s003lbl.pdf",
              "date": "20090326",
              "type": "Label"
            },
            {
              "id": "21860",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021892Orig1s003.pdf",
              "date": "20111010",
              "type": "Review"
            },
            {
              "id": "28792",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021097s013,021892s003ltr.pdf",
              "date": "20090327",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20070918",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6397",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021892s001ltr.pdf",
              "date": "20070925",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021892",
      "sponsor_name": "SALIX PHARMS",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "OSMOPREP",
          "active_ingredients": [
            {
              "name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS",
              "strength": "0.398GM"
            },
            {
              "name": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
              "strength": "1.102GM **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"
        }
      ]
    }
  ]
}