{
  "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": "2026-09-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20160407",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20130508",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36243",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021159s020lbl.pdf",
              "date": "20130514",
              "type": "Label"
            },
            {
              "id": "4504",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021159Orig1s020ltr.pdf",
              "date": "20130510",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20121206",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4503",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021159Orig1s019ltr.pdf",
              "date": "20121211",
              "type": "Letter"
            },
            {
              "id": "36242",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021159s019lbl.pdf",
              "date": "20121207",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20060612",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36241",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021159s009lbl.pdf",
              "date": "20060614",
              "type": "Label"
            },
            {
              "id": "26938",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021159s009LTR.pdf",
              "date": "20060614",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20150203",
          "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": "20030228",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "41994",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21159_Loprox.html",
              "date": "20030708",
              "type": "Review"
            },
            {
              "id": "26937",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21159ltr.pdf",
              "date": "20030310",
              "type": "Letter"
            },
            {
              "id": "36240",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021159lbl.pdf",
              "date": "20030228",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20040226",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "4502",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21159scp001ltr.pdf",
              "date": "20040227",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021159",
      "sponsor_name": "BAUSCH",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "LOPROX",
          "active_ingredients": [
            {
              "name": "CICLOPIROX",
              "strength": "1%"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SHAMPOO",
          "route": "TOPICAL",
          "marketing_status": "Discontinued",
          "te_code": "AT"
        }
      ]
    }
  ]
}