{
  "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": "4",
          "submission_status": "AP",
          "submission_status_date": "20190625",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "59173",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209604Orig1s004ltr.pdf",
              "date": "20190626",
              "type": "Letter"
            },
            {
              "id": "59182",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209604s004lbl.pdf",
              "date": "20190627",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20181218",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56906",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s002lbl.pdf",
              "date": "20181220",
              "type": "Label"
            },
            {
              "id": "56923",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209604Orig1s002ltr.pdf",
              "date": "20181221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20170803",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "49240",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209604s000lbl.pdf",
              "date": "20170804",
              "type": "Label"
            },
            {
              "id": "49255",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209604Orig1s000ltr.pdf",
              "date": "20170807",
              "type": "Letter"
            },
            {
              "id": "50203",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209604Orig1s000TOC.html",
              "date": "20171027",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20180730",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "55066",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209604s003lbl.pdf",
              "date": "20180731",
              "type": "Label"
            },
            {
              "id": "55083",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209604s003ltr.pdf",
              "date": "20180803",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20240924",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "79734",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209604Orig1s011ltr.pdf",
              "date": "20240926",
              "type": "Letter"
            },
            {
              "id": "79739",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209604s011lbl.pdf",
              "date": "20240926",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA209604",
      "sponsor_name": "ACCORD HLTHCARE",
      "openfda": {
        "application_number": [
          "NDA209604"
        ],
        "brand_name": [
          "GEMCITABINE"
        ],
        "generic_name": [
          "GEMCITABINE"
        ],
        "manufacturer_name": [
          "BluePoint Laboratories"
        ],
        "product_ndc": [
          "68001-342",
          "68001-348",
          "68001-350",
          "68001-359"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GEMCITABINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1998783"
        ],
        "spl_id": [
          "049982fe-a321-b868-e063-6294a90ae861"
        ],
        "spl_set_id": [
          "4031017d-d768-46de-8081-476bcb883f5e"
        ],
        "package_ndc": [
          "68001-342-34",
          "68001-348-36",
          "68001-350-68",
          "68001-359-37"
        ],
        "unii": [
          "U347PV74IL"
        ]
      },
      "products": [
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "GEMCITABINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "GEMCITABINE HYDROCHLORIDE",
              "strength": "1.5GM/15ML (100MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "GEMCITABINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "GEMCITABINE HYDROCHLORIDE",
              "strength": "200MG/2ML (100MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "GEMCITABINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "GEMCITABINE HYDROCHLORIDE",
              "strength": "2GM/20ML (100MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "GEMCITABINE HYDROCHLORIDE",
          "active_ingredients": [
            {
              "name": "GEMCITABINE HYDROCHLORIDE",
              "strength": "1GM/10ML (100MG/ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "INTRAVENOUS",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}