{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20191105",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "60796",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022563Orig1s007,%20s008.pdf",
              "date": "20191108",
              "type": "Letter"
            },
            {
              "id": "62874",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/487_22563S7 calcipotriene clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20101006",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "38841",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022563s000lbl.pdf",
              "date": "20101012",
              "type": "Label"
            },
            {
              "id": "42558",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563_sorilux_toc.html",
              "date": "20110503",
              "type": "Review"
            },
            {
              "id": "7533",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022563s000ltr.pdf",
              "date": "20101013",
              "type": "Letter"
            },
            {
              "id": "24341",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022563Orig1s000SumR.pdf",
              "date": "20110503",
              "type": "Summary Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20110421",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "7534",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022563s001ltr.pdf",
              "date": "20110425",
              "type": "Letter"
            },
            {
              "id": "17710",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022563s001lbl.pdf",
              "date": "20110422",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20191105",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60795",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022563Orig1s007, s008.pdf",
              "date": "20191108",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20190506",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "58591",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022563s006lbl.pdf",
              "date": "20190507",
              "type": "Label"
            },
            {
              "id": "62873",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/22563S6 calcipotriene multidisciplinary prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "62875",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/488_22563S7 calcipotriene clinpharm prea_0.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20150710",
          "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": "20120927",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "17711",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022563s002lbl.pdf",
              "date": "20120928",
              "type": "Label"
            },
            {
              "id": "29861",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022563Orig1s002ltr.pdf",
              "date": "20121002",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA022563",
      "sponsor_name": "MAYNE PHARMA",
      "openfda": {
        "application_number": [
          "NDA022563"
        ],
        "brand_name": [
          "CALCIPOTRIENE",
          "SORILUX"
        ],
        "generic_name": [
          "CALCIPOTRIENE"
        ],
        "manufacturer_name": [
          "Mayne Pharma"
        ],
        "product_ndc": [
          "51862-512",
          "51862-376"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CALCIPOTRIENE"
        ],
        "rxcui": [
          "1020035",
          "1020039"
        ],
        "spl_id": [
          "8200e8ca-3486-4e51-8a3c-6efee8913d50",
          "cf0e1842-298b-47e7-9d51-f0789ae086ca"
        ],
        "spl_set_id": [
          "26756ac7-a80c-49db-97bb-351f76ad8a71",
          "51f208d0-7b3f-44cc-8bed-92fa3d2e7bbe"
        ],
        "package_ndc": [
          "51862-512-60",
          "51862-376-60",
          "51862-376-12"
        ],
        "nui": [
          "M0022797",
          "N0000175849"
        ],
        "pharm_class_cs": [
          "Vitamin D [CS]"
        ],
        "pharm_class_epc": [
          "Vitamin D Analog [EPC]"
        ],
        "unii": [
          "143NQ3779B"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "SORILUX",
          "active_ingredients": [
            {
              "name": "CALCIPOTRIENE",
              "strength": "0.005%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "AEROSOL, FOAM",
          "route": "TOPICAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}