{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20200323",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "62287",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207695s007s009s010lbl.pdf",
              "date": "20200324",
              "type": "Label"
            },
            {
              "id": "62305",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207695Orig1s007, s009, s010ltr.pdf",
              "date": "20200324",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20200323",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "62286",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207695s007s009s010lbl.pdf",
              "date": "20200324",
              "type": "Label"
            },
            {
              "id": "62304",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207695Orig1s007, s009, s010ltr.pdf",
              "date": "20200324",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20161214",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "46165",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207695Orig1s000ltr.pdf",
              "date": "20161215",
              "type": "Letter"
            },
            {
              "id": "46421",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207695s000lbl.pdf",
              "date": "20161221",
              "type": "Label"
            },
            {
              "id": "46929",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207695Orig1s000TOC.html",
              "date": "20170123",
              "type": "Review"
            },
            {
              "id": "52578",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/49_207695 crisaborole CDTL clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric CDTL Review"
            },
            {
              "id": "52579",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/50_207695 crisaborole clinical prea-EMV.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "52580",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/51_207695 crisaborole clinpharm prea.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "52581",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/52_207695 crisaborole statistical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "63897",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N207695_crisaborole_Orig_WR.pdf",
              "date": "19000101",
              "type": "Pediatric Written Request"
            },
            {
              "id": "63898",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/N207695_crisaborole_Amend_1_0.pdf",
              "date": "19000101",
              "type": "Pediatric Amendment 1"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20230403",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "73946",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207695Orig1s012ltr.pdf",
              "date": "20230404",
              "type": "Letter"
            },
            {
              "id": "73961",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207695s012lbl.pdf",
              "date": "20230407",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20200323",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "62288",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207695s007s009s010lbl.pdf",
              "date": "20200324",
              "type": "Label"
            },
            {
              "id": "62306",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207695Orig1s007, s009, s010ltr.pdf",
              "date": "20200324",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20171016",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50089",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207695Orig1s002ltr.pdf",
              "date": "20171018",
              "type": "Letter"
            },
            {
              "id": "50148",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207695s002lbl.pdf",
              "date": "20171023",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA207695",
      "sponsor_name": "ANACOR PHARMS INC",
      "openfda": {
        "application_number": [
          "NDA207695"
        ],
        "brand_name": [
          "EUCRISA"
        ],
        "generic_name": [
          "CRISABOROLE"
        ],
        "manufacturer_name": [
          "Pfizer Laboratories Div Pfizer Inc"
        ],
        "product_ndc": [
          "55724-211"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CRISABOROLE"
        ],
        "rxcui": [
          "1865957",
          "1865962"
        ],
        "spl_id": [
          "e5457495-d465-4c0a-a1ea-603c4c5823fb"
        ],
        "spl_set_id": [
          "609b77de-1ca3-4783-b8f5-01a9c0f1d77d"
        ],
        "package_ndc": [
          "55724-211-21",
          "55724-211-11",
          "55724-211-42",
          "55724-211-23"
        ],
        "nui": [
          "N0000182961",
          "N0000182960"
        ],
        "pharm_class_epc": [
          "Phosphodiesterase 4 Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Phosphodiesterase 4 Inhibitors [MoA]"
        ],
        "unii": [
          "Q2R47HGR7P"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "EUCRISA",
          "active_ingredients": [
            {
              "name": "CRISABOROLE",
              "strength": "2%"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "OINTMENT",
          "route": "TOPICAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}