{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19980130",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "22211",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/50731.pdf",
              "date": "19980130",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20020612",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19990429",
          "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": "20180927",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN",
          "application_docs": [
            {
              "id": "55762",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050731Orig1s008Rplacementltr.pdf",
              "date": "20181001",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20010302",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA050731",
      "sponsor_name": "HIKMA",
      "openfda": {
        "application_number": [
          "NDA050731"
        ],
        "brand_name": [
          "DAUNORUBICIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "DAUNORUBICIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9550",
          "0143-9551"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DAUNORUBICIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "309650",
          "2002002"
        ],
        "spl_id": [
          "d77dc365-6db8-4bdc-81fc-7ac80bcc7699"
        ],
        "spl_set_id": [
          "227784a8-ce68-4dd4-8ac5-a65265969677"
        ],
        "package_ndc": [
          "0143-9551-01",
          "0143-9551-10",
          "0143-9550-01"
        ],
        "unii": [
          "UD984I04LZ"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "DAUNORUBICIN HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "DAUNORUBICIN HYDROCHLORIDE",
              "strength": "EQ 5MG BASE/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}