{
  "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": "1",
          "submission_status": "AP",
          "submission_status_date": "20070118",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5650",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021529s001ltr.pdf",
              "date": "20070125",
              "type": "Letter"
            },
            {
              "id": "72098",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021529Orig1s001.pdf",
              "date": "20220916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20260116",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "84805",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021529s027lbl.pdf",
              "date": "20260122",
              "type": "Label"
            },
            {
              "id": "84816",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021529Orig1s027ltr.pdf",
              "date": "20260122",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20200924",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64678",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021529Orig1s019,s020ltr.pdf",
              "date": "20200925",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20170519",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "48491",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021529s015lbl.pdf",
              "date": "20170523",
              "type": "Label"
            },
            {
              "id": "48501",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021529Orig1s015ltr.pdf",
              "date": "20170523",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20230929",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75637",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf",
              "date": "20231030",
              "type": "Label"
            },
            {
              "id": "75643",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021529Orig1s021;s022;s024ltr.pdf",
              "date": "20231003",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20160314",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "28034",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021529Orig1s013ltr.pdf",
              "date": "20160316",
              "type": "Letter"
            },
            {
              "id": "37165",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021529s013lbl.pdf",
              "date": "20160315",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20140703",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "72096",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021529Orig1s008.pdf",
              "date": "20220916",
              "type": "Review"
            },
            {
              "id": "37163",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021529s008lblrev.pdf",
              "date": "20140709",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20150819",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "5654",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021529Orig1s011ltr.pdf",
              "date": "20150821",
              "type": "Letter"
            },
            {
              "id": "72097",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021529Orig1s011.pdf",
              "date": "20220916",
              "type": "Review"
            },
            {
              "id": "15696",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021529s011lbl.pdf",
              "date": "20150820",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20120201",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37161",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021529s006lbl.pdf",
              "date": "20120206",
              "type": "Label"
            },
            {
              "id": "5652",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021529s006ltr.pdf",
              "date": "20120203",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20090219",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37160",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021529s004lbl.pdf",
              "date": "20090220",
              "type": "Label"
            },
            {
              "id": "5651",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021529s004ltr.pdf",
              "date": "20090223",
              "type": "Letter"
            },
            {
              "id": "72099",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021529Orig1s004.pdf",
              "date": "20220916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20060717",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "37159",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021529lbl.pdf",
              "date": "20060721",
              "type": "Label"
            },
            {
              "id": "42202",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021529_implanon_toc.html",
              "date": "20091119",
              "type": "Review"
            },
            {
              "id": "28032",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021529s000_ltr.pdf",
              "date": "20060721",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20190422",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "58372",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021529Orig1s018ltr.pdf",
              "date": "20190424",
              "type": "Letter"
            },
            {
              "id": "58406",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021529s018lbl.pdf",
              "date": "20190425",
              "type": "Label"
            },
            {
              "id": "72095",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/021529Orig1s018.pdf",
              "date": "20220916",
              "type": "Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20230929",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75639",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf",
              "date": "20231030",
              "type": "Label"
            },
            {
              "id": "75645",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021529Orig1s021;s022;s024ltr.pdf",
              "date": "20231003",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20230929",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "75638",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021529s021s022s024lbl.pdf",
              "date": "20231002",
              "type": "Label"
            },
            {
              "id": "75644",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021529Orig1s021;s022;s024ltr.pdf",
              "date": "20231003",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20130612",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20200924",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "64679",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021529Orig1s019,s020ltr.pdf",
              "date": "20200925",
              "type": "Letter"
            },
            {
              "id": "64690",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021529s019s020lbl.pdf",
              "date": "20200925",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20150903",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20110513",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "5653",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021529s007ltr.pdf",
              "date": "20110519",
              "type": "Letter"
            },
            {
              "id": "71935",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021529Orig1s007.pdf",
              "date": "20220826",
              "type": "Review"
            },
            {
              "id": "37162",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021529s007lbl.pdf",
              "date": "20110516",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20130927",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "37164",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021529s010lbl.pdf",
              "date": "20131001",
              "type": "Label"
            },
            {
              "id": "28033",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021529Orig1s010ltr.pdf",
              "date": "20131001",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021529",
      "sponsor_name": "ORGANON",
      "openfda": {
        "application_number": [
          "NDA021529"
        ],
        "brand_name": [
          "NEXPLANON"
        ],
        "generic_name": [
          "ETONOGESTREL"
        ],
        "manufacturer_name": [
          "Organon LLC"
        ],
        "product_ndc": [
          "78206-145"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "ETONOGESTREL"
        ],
        "rxcui": [
          "389221",
          "1111011"
        ],
        "spl_id": [
          "11bdb463-b672-4e94-993d-bd1b22dc6654"
        ],
        "spl_set_id": [
          "487f8a62-e142-457c-97cc-2e398fde7594"
        ],
        "package_ndc": [
          "78206-145-01"
        ],
        "nui": [
          "M0447349",
          "N0000175602"
        ],
        "pharm_class_cs": [
          "Progesterone Congeners [CS]"
        ],
        "pharm_class_epc": [
          "Progestin [EPC]"
        ],
        "unii": [
          "304GTH6RNH"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "IMPLANON",
          "active_ingredients": [
            {
              "name": "ETONOGESTREL",
              "strength": "68MG/IMPLANT"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "IMPLANT",
          "route": "IMPLANTATION",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "NEXPLANON",
          "active_ingredients": [
            {
              "name": "ETONOGESTREL",
              "strength": "68MG/IMPLANT"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "IMPLANT",
          "route": "IMPLANTATION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}