{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19931021",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20220524",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "71146",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020209Orig1s014ltr.pdf",
              "date": "20220525",
              "type": "Letter"
            },
            {
              "id": "71629",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020209Orig1s014lbl.pdf",
              "date": "20220725",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19920930",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20150819",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20150126",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19970808",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20150303",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20040123",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "24577",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19828slr009,20209slr005ltr.pdf",
              "date": "20040129",
              "type": "Letter"
            },
            {
              "id": "34369",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19828slr009,20209slr005_oxistat_lbl.pdf",
              "date": "20040202",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA020209",
      "sponsor_name": "ANI PHARMS",
      "openfda": {
        "application_number": [
          "NDA020209"
        ],
        "brand_name": [
          "OXISTAT"
        ],
        "generic_name": [
          "OXICONAZOLE NITRATE"
        ],
        "manufacturer_name": [
          "ANI Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "62559-285"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "OXICONAZOLE NITRATE"
        ],
        "rxcui": [
          "207249",
          "312140"
        ],
        "spl_id": [
          "c38f8751-f5da-4333-b12a-2ca8c1816a32"
        ],
        "spl_set_id": [
          "64ef2286-0f56-4a8a-b07b-4a597f078ae0"
        ],
        "package_ndc": [
          "62559-285-30",
          "62559-285-60",
          "62559-285-06"
        ],
        "unii": [
          "RQ8UL4C17S"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "OXISTAT",
          "active_ingredients": [
            {
              "name": "OXICONAZOLE NITRATE",
              "strength": "EQ 1% BASE"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "LOTION",
          "route": "TOPICAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}