{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20170203",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47100",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s013lbl.pdf",
              "date": "20170206",
              "type": "Label"
            },
            {
              "id": "47127",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022504rig1s013ltr.pdf",
              "date": "20170207",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20140619",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38770",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022504s011lbl.pdf",
              "date": "20140623",
              "type": "Label"
            },
            {
              "id": "7465",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022504Orig1s011ltr.pdf",
              "date": "20140623",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20140227",
          "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": "20140115",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20111222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "42542",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022504Orig1s005.pdf",
              "date": "20140707",
              "type": "Review"
            },
            {
              "id": "17652",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s005lbl.pdf",
              "date": "20111223",
              "type": "Label"
            },
            {
              "id": "29791",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022504s005ltr.pdf",
              "date": "20111228",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20170713",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "48981",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s016lbl.pdf",
              "date": "20170714",
              "type": "Label"
            },
            {
              "id": "48982",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022504s016lbl.pdf#page=15",
              "date": "20170714",
              "type": "Medication Guide"
            },
            {
              "id": "48988",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022504Orig1s016ltr.pdf",
              "date": "20170714",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20161025",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "45678",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022504Orig1s014ltr.pdf",
              "date": "20161027",
              "type": "Letter"
            },
            {
              "id": "45744",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022504s014lbl.pdf",
              "date": "20161101",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20101123",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "38769",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022504s000lbl.pdf",
              "date": "20101123",
              "type": "Label"
            },
            {
              "id": "44506",
              "title": "REMS",
              "url": "http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=7",
              "date": "20110404",
              "type": "Other"
            },
            {
              "id": "44763",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022504Orig1s000SumR.pdf",
              "date": "20110916",
              "type": "Summary Review"
            },
            {
              "id": "22038",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022504_axiron_toc.html",
              "date": "20110916",
              "type": "Review"
            },
            {
              "id": "29789",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022504s000ltr.pdf",
              "date": "20101129",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20150511",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "17653",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022504s012lbl.pdf",
              "date": "20150513",
              "type": "Label"
            },
            {
              "id": "29792",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022504Orig1s012ltr.pdf",
              "date": "20150513",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20130529",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20110331",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "17651",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022504s002lbl.pdf",
              "date": "20110401",
              "type": "Label"
            },
            {
              "id": "29790",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022504s002ltr.pdf",
              "date": "20110404",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20170123",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "46988",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022504Orig1s015ltr.pdf",
              "date": "20170127",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA022504",
      "sponsor_name": "ELI LILLY AND CO",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "AXIRON",
          "active_ingredients": [
            {
              "name": "TESTOSTERONE",
              "strength": "30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION, METERED",
          "route": "TRANSDERMAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}