{
  "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": "16",
          "submission_status": "AP",
          "submission_status_date": "20250228",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "81413",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/008975Orig1s016lbl.pdf",
              "date": "20250304",
              "type": "Label"
            },
            {
              "id": "81414",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/008975Orig1s016ltr.pdf",
              "date": "20250304",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20231026",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75966",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/008975Orig1s012ltr.pdf",
              "date": "20231027",
              "type": "Letter"
            },
            {
              "id": "75980",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008975s012lbl.pdf",
              "date": "20231027",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20211029",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "77423",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/008975Orig1s008.pdf",
              "date": "20240208",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19771208",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20241213",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "80578",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008975s015lbl.pdf",
              "date": "20241216",
              "type": "Label"
            },
            {
              "id": "80588",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/008975Orig1s015ltr.pdf",
              "date": "20241216",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "19770525",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19540616",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer"
        }
      ],
      "application_number": "NDA008975",
      "sponsor_name": "ANI PHARMS",
      "openfda": {
        "application_number": [
          "NDA008975"
        ],
        "brand_name": [
          "PURIFIED CORTROPHIN GEL"
        ],
        "generic_name": [
          "REPOSITORY CORTICOTROPIN"
        ],
        "manufacturer_name": [
          "ANI Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "62559-860",
          "62559-861"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "CORTICOTROPIN"
        ],
        "rxcui": [
          "309541",
          "2584475",
          "2685293",
          "2685298",
          "2707578",
          "2707580"
        ],
        "spl_id": [
          "acbfd15f-c384-4b64-b444-33952abc3566"
        ],
        "spl_set_id": [
          "f27544ee-a0e2-4d84-b193-1c9efdf9e34c"
        ],
        "package_ndc": [
          "62559-860-15",
          "62559-860-11",
          "62559-861-35",
          "62559-861-11"
        ],
        "nui": [
          "M0000499",
          "N0000175941"
        ],
        "pharm_class_cs": [
          "Adrenocorticotropic Hormone [CS]"
        ],
        "pharm_class_epc": [
          "Adrenocorticotropic Hormone [EPC]"
        ],
        "unii": [
          "K0U68Q2TXA"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "PURIFIED CORTROPHIN GEL",
          "active_ingredients": [
            {
              "name": "CORTICOTROPIN",
              "strength": "40 UNITS/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "PURIFIED CORTROPHIN GEL",
          "active_ingredients": [
            {
              "name": "CORTICOTROPIN",
              "strength": "80 UNITS/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}