{
  "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": "20090715",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20080709",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20050121",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20070119",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20060714",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20020627",
          "application_docs": [
            {
              "id": "43029",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075841_s000_PamidronateTOC.html",
              "date": "20060420",
              "type": "Review"
            },
            {
              "id": "44272",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm",
              "date": "20080107",
              "type": "Other Important Information from FDA"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20200107",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20060519",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA075841",
      "sponsor_name": "HOSPIRA",
      "openfda": {
        "application_number": [
          "ANDA075841"
        ],
        "brand_name": [
          "PAMIDRONATE DISODIUM"
        ],
        "generic_name": [
          "PAMIDRONATE DISODIUM"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "61703-324",
          "61703-325",
          "61703-326"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PAMIDRONATE DISODIUM"
        ],
        "spl_id": [
          "d1f55dd9-cc5b-4162-81be-53736ffbb5a7"
        ],
        "spl_set_id": [
          "9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23"
        ],
        "package_ndc": [
          "61703-325-18",
          "61703-326-18",
          "61703-324-18"
        ],
        "unii": [
          "8742T8ZQZA"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "PAMIDRONATE DISODIUM",
          "active_ingredients": [
            {
              "name": "PAMIDRONATE DISODIUM",
              "strength": "90MG/10ML (9MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP2"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "PAMIDRONATE DISODIUM",
          "active_ingredients": [
            {
              "name": "PAMIDRONATE DISODIUM",
              "strength": "30MG/10ML (3MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP2"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "PAMIDRONATE DISODIUM",
          "active_ingredients": [
            {
              "name": "PAMIDRONATE DISODIUM",
              "strength": "60MG/10ML (6MG/ML)"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}