{
  "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": "11",
          "submission_status": "AP",
          "submission_status_date": "20000907",
          "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": "19980731",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "19960125",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20180328",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "53570",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019716s032lbl.pdf",
              "date": "20180401",
              "type": "Label"
            },
            {
              "id": "53587",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018741Orig1s038,019555Orig1s034,019716Orig1s032ltr.pdf",
              "date": "20180401",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "19920701",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19890524",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20140813",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "11645",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019716s030lbl.pdf",
              "date": "20140815",
              "type": "Label"
            },
            {
              "id": "19113",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018741s036,019555s033,019716s030ltr.pdf",
              "date": "20140814",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20060828",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "11644",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019716s022lbl.pdf",
              "date": "20060828",
              "type": "Label"
            },
            {
              "id": "19112",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s022ltr.pdf",
              "date": "20060918",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20010511",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "19990514",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19880801",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "19980615",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20190501",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58523",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018741Orig1s040;019555Orig1s035;019716Orig1s033ltr.pdf",
              "date": "20190502",
              "type": "Letter"
            },
            {
              "id": "58525",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019716s033lbl.pdf",
              "date": "20190502",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20051007",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1524",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019716s006ltr.pdf",
              "date": "20051014",
              "type": "Letter"
            },
            {
              "id": "33879",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019716s006lbl.pdf",
              "date": "20051014",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19900801",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "19890406",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20060424",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1525",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019716s021LTR.pdf",
              "date": "20060425",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA019716",
      "sponsor_name": "ORGANON",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "DIPROLENE",
          "active_ingredients": [
            {
              "name": "BETAMETHASONE DIPROPIONATE",
              "strength": "EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "LOTION, AUGMENTED",
          "route": "TOPICAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}