{
  "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": "4",
          "submission_status": "AP",
          "submission_status_date": "20180220",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "52690",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204153s004s005lbl.pdf",
              "date": "20180223",
              "type": "Label"
            },
            {
              "id": "52728",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204153Orig1s004s005ltr.pdf",
              "date": "20180226",
              "type": "Letter"
            },
            {
              "id": "63125",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/241_204153S4-luliconazole-CDTL-clinical-prea.pdf",
              "date": "19000101",
              "type": "Pediatric CDTL Review"
            },
            {
              "id": "63127",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/240_204153S4-luliconazole-clinical-prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "63129",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/239_204153S4-luliconazole-clinpharm-prea.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "63130",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/238_204153S4-luliconazole-statistical-prea.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20170208",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47139",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204153Orig1s002ltr.pdf",
              "date": "20170209",
              "type": "Letter"
            },
            {
              "id": "47148",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204153s002lbl.pdf",
              "date": "20170209",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20180220",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "52691",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204153s004s005lbl.pdf",
              "date": "20180223",
              "type": "Label"
            },
            {
              "id": "52729",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204153Orig1s004s005ltr.pdf",
              "date": "20180226",
              "type": "Letter"
            },
            {
              "id": "63124",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/237_204153S5-luliconazole-CDTL-clinical-prea.pdf",
              "date": "19000101",
              "type": "Pediatric CDTL Review"
            },
            {
              "id": "63126",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/236_204153S5-luliconazole-clinical-prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "63128",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/235_204153S5-luliconazole-clinpharm-prea.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20160607",
          "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": "20131114",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "43457",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204153Orig1s000TOC.html",
              "date": "20131212",
              "type": "Review"
            },
            {
              "id": "19531",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204153s000lbl.pdf",
              "date": "20131115",
              "type": "Label"
            },
            {
              "id": "24460",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204153Orig1s000SumR.pdf",
              "date": "20131212",
              "type": "Summary Review"
            },
            {
              "id": "32521",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204153Orig1s000ltr.pdf",
              "date": "20131115",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA204153",
      "sponsor_name": "BAUSCH",
      "openfda": {
        "application_number": [
          "NDA204153"
        ],
        "brand_name": [
          "LUZU",
          "LULICONAZOLE"
        ],
        "generic_name": [
          "LULICONAZOLE"
        ],
        "manufacturer_name": [
          "Bausch Health US, LLC",
          "Oceanside Pharmaceuticals"
        ],
        "product_ndc": [
          "99207-850",
          "68682-850"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "LULICONAZOLE"
        ],
        "rxcui": [
          "1482684",
          "1482689"
        ],
        "spl_id": [
          "f18334bd-5ed1-43b2-87ba-80b803b54387",
          "9c57ca2a-cc38-40fc-ac2e-40b21cc18c43"
        ],
        "spl_set_id": [
          "a7016010-ce43-4c09-8d21-aeb697ffed31",
          "7ccda3ba-9c98-468d-83c6-7f0cc7c88c33"
        ],
        "package_ndc": [
          "99207-850-60",
          "99207-850-02",
          "68682-850-60"
        ],
        "nui": [
          "N0000175487",
          "M0002083",
          "N0000182140"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "pharm_class_moa": [
          "Cytochrome P450 2C19 Inhibitors [MoA]"
        ],
        "unii": [
          "RE91AN4S8G"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "LUZU",
          "active_ingredients": [
            {
              "name": "LULICONAZOLE",
              "strength": "1%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "CREAM",
          "route": "TOPICAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}