{
  "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": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20180622",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54709",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021797Orig1s19_21798Orig11s021ltr.pdf",
              "date": "20180627",
              "type": "Letter"
            },
            {
              "id": "54814",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021798s021lbl.pdf",
              "date": "20180706",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20080603",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6211",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s006, 021798s007ltr.pdf",
              "date": "20080606",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20050329",
          "review_priority": "PRIORITY",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "42316",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21797_21798_BaracludeTOC.html",
              "date": "20051206",
              "type": "Review"
            },
            {
              "id": "16384",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021797,021798lbl.pdf",
              "date": "20050331",
              "type": "Label"
            },
            {
              "id": "28617",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021797,021798ltr.pdf",
              "date": "20050331",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20101015",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "16388",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021797s010,021798s011lbl.pdf",
              "date": "20101029",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20070724",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37670",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s003,021798s003lbl.pdf",
              "date": "20070727",
              "type": "Label"
            },
            {
              "id": "6209",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s003, 021798s003ltr.pdf",
              "date": "20070727",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20070223",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "37669",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s001,021798s001lbl.pdf",
              "date": "20070226",
              "type": "Label"
            },
            {
              "id": "6207",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s001,021798s001ltr.pdf",
              "date": "20070306",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20131219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "16390",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021797s017,021798s018lbl.pdf",
              "date": "20131223",
              "type": "Label"
            },
            {
              "id": "28620",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021797Orig1s017,021798Orig1s018ltr.pdf",
              "date": "20131220",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20191106",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "60813",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021797Orig1s023, 021798Orig1s024ltr.pdf",
              "date": "20191112",
              "type": "Letter"
            },
            {
              "id": "60973",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021797s023,021798s024lbl.pdf",
              "date": "20191119",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20121012",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "37673",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf",
              "date": "20121015",
              "type": "Label"
            },
            {
              "id": "6214",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf",
              "date": "20121015",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20090716",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "6212",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s008,021798s008ltr.pdf",
              "date": "20090722",
              "type": "Letter"
            },
            {
              "id": "16386",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s008, 021798s008lbl.pdf",
              "date": "20090724",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20121012",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "16389",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021797s013s014,021798s014s016lbl.pdf",
              "date": "20121015",
              "type": "Label"
            },
            {
              "id": "28619",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021797Orig1s013,s014 021798Orig1s014,s016ltr.pdf",
              "date": "20121015",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20080725",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "37671",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021797s005,021798s006lbl.pdf",
              "date": "20080813",
              "type": "Label"
            },
            {
              "id": "6210",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021797s005, 021798s006ltr.pdf",
              "date": "20080731",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20101228",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37672",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021798s012lbl.pdf",
              "date": "20101228",
              "type": "Label"
            },
            {
              "id": "28618",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021797s011,021798s012ltr.pdf",
              "date": "20110104",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20090225",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6213",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021797s009,021798s010ltr.pdf",
              "date": "20090227",
              "type": "Letter"
            },
            {
              "id": "16387",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021797s009,021798s010lbl.pdf",
              "date": "20090317",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20070327",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "6208",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021797s002, 021798s002ltr.pdf",
              "date": "20070331",
              "type": "Letter"
            },
            {
              "id": "16385",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021797s002,021798s002lbl.pdf",
              "date": "20070331",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20140320",
          "review_priority": "PRIORITY",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "16391",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021797s018,021798s019lbl.pdf",
              "date": "20140325",
              "type": "Label"
            },
            {
              "id": "28621",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021797Orig1s18,021798Orig1s19ltr.pdf",
              "date": "20140321",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20130618",
          "review_priority": "PRIORITY",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20181220",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56953",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021797Orig1s021, 021798Orig1s023Ltr.pdf",
              "date": "20181221",
              "type": "Letter"
            },
            {
              "id": "56994",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021797s021,021798s023lbl.pdf",
              "date": "20181221",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA021798",
      "sponsor_name": "BRISTOL MYERS SQUIBB",
      "openfda": {
        "application_number": [
          "NDA021798"
        ],
        "brand_name": [
          "BARACLUDE"
        ],
        "generic_name": [
          "ENTECAVIR"
        ],
        "manufacturer_name": [
          "E.R. Squibb & Sons, L.L.C."
        ],
        "product_ndc": [
          "0003-1614",
          "0003-1611",
          "0003-1612"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ENTECAVIR"
        ],
        "rxcui": [
          "485434",
          "485436",
          "485536",
          "578457",
          "578459",
          "607579"
        ],
        "spl_id": [
          "275a2584-65d6-40f8-8aac-49eb54479f6d"
        ],
        "spl_set_id": [
          "046e61c9-9298-4b2e-b76e-b26b81fecd20"
        ],
        "package_ndc": [
          "0003-1611-12",
          "0003-1611-13",
          "0003-1612-12",
          "0003-1614-12"
        ],
        "unii": [
          "5968Y6H45M"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "BARACLUDE",
          "active_ingredients": [
            {
              "name": "ENTECAVIR",
              "strength": "0.05MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "SOLUTION",
          "route": "ORAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}