{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20160624",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20211118",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20231211",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20090807",
          "application_docs": [
            {
              "id": "22629",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078813Orig1s000Approv.pdf",
              "date": "20130410",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "ANDA078813",
      "sponsor_name": "HOSPIRA WORLDWIDE",
      "openfda": {
        "application_number": [
          "ANDA078813"
        ],
        "brand_name": [
          "OXALIPLATIN"
        ],
        "generic_name": [
          "OXALIPLATIN"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "61703-363"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "OXALIPLATIN"
        ],
        "rxcui": [
          "1736776",
          "1736781"
        ],
        "spl_id": [
          "4edbffab-0628-4c35-ac6a-76a629f3c9dd"
        ],
        "spl_set_id": [
          "e51a62ba-d163-4c57-835c-8c86cf097e40"
        ],
        "package_ndc": [
          "61703-363-18",
          "61703-363-22"
        ],
        "nui": [
          "N0000175413",
          "N0000175073"
        ],
        "pharm_class_epc": [
          "Platinum-based Drug [EPC]"
        ],
        "unii": [
          "04ZR38536J"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "OXALIPLATIN",
          "active_ingredients": [
            {
              "name": "OXALIPLATIN",
              "strength": "100MG/20ML (5MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "OXALIPLATIN",
          "active_ingredients": [
            {
              "name": "OXALIPLATIN",
              "strength": "50MG/10ML (5MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INTRAVENOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}