{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20100416",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "17323",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022404lbl.pdf",
              "date": "20100503",
              "type": "Label"
            },
            {
              "id": "22012",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022404s000_oravig_toc.html",
              "date": "20101223",
              "type": "Review"
            },
            {
              "id": "24297",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022404Orig1s000SumR.pdf",
              "date": "20101223",
              "type": "Summary Review"
            },
            {
              "id": "29685",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022404s000ltr.pdf",
              "date": "20100503",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20200204",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "61777",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022404Orig1s005ltr.pdf",
              "date": "20200205",
              "type": "Letter"
            },
            {
              "id": "61781",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022404s005lbl.pdf",
              "date": "20200205",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20130305",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17324",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022404s003lbl.pdf",
              "date": "20130308",
              "type": "Label"
            },
            {
              "id": "29687",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022404Orig1s003ltr.pdf",
              "date": "20130306",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20110408",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38662",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022404s002lbl.pdf",
              "date": "20110411",
              "type": "Label"
            },
            {
              "id": "29686",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022404s002ltr.pdf",
              "date": "20110413",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA022404",
      "sponsor_name": "GALT PHARMS",
      "openfda": {
        "application_number": [
          "NDA022404"
        ],
        "brand_name": [
          "ORAVIG"
        ],
        "generic_name": [
          "MICONAZOLE"
        ],
        "manufacturer_name": [
          "Galt Pharmaceuticals, LLC"
        ],
        "product_ndc": [
          "61825-303"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "BUCCAL"
        ],
        "substance_name": [
          "MICONAZOLE"
        ],
        "rxcui": [
          "998548",
          "998550"
        ],
        "spl_id": [
          "47da8a7f-0d47-f1cd-e063-6394a90a84ad"
        ],
        "spl_set_id": [
          "dc2427ff-e566-4b48-b289-9e51c011250a"
        ],
        "package_ndc": [
          "61825-303-14"
        ],
        "nui": [
          "N0000175487",
          "M0002083"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "unii": [
          "7NNO0D7S5M"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ORAVIG",
          "active_ingredients": [
            {
              "name": "MICONAZOLE",
              "strength": "50MG"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "TABLET",
          "route": "BUCCAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}