{
  "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": "3",
          "submission_status": "AP",
          "submission_status_date": "19980727",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "41442",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19726-s024_Zoladax.html",
              "date": "19980727",
              "type": "Review"
            },
            {
              "id": "12760",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/19726s024lbl.pdf",
              "date": "19980727",
              "type": "Label"
            },
            {
              "id": "25217",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19726s024ltr.pdf",
              "date": "19980727",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20130618",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12763",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf",
              "date": "20130617",
              "type": "Label"
            },
            {
              "id": "2771",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf",
              "date": "20130620",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19990414",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20110114",
          "review_priority": "901 REQUIRED",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12762",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020578s032lbl.pdf",
              "date": "20110120",
              "type": "Label"
            },
            {
              "id": "2770",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019726s054,020578s032ltr.pdf",
              "date": "20110120",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20020228",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25218",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19726s37ltr.pdf",
              "date": "20020228",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20090831",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25220",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf",
              "date": "20100120",
              "type": "Letter"
            },
            {
              "id": "34875",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf",
              "date": "20090917",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19960111",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "23584",
              "url": "http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm",
              "date": "20111220",
              "type": "Other Important Information from FDA"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20040624",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2767",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19726slr042,20578slr020ltr.pdf",
              "date": "20040625",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20010309",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20000620",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "53",
          "submission_status": "AP",
          "submission_status_date": "20260506",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "85846",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/020578Orig1s053ltr.pdf",
              "date": "20260508",
              "type": "Letter"
            },
            {
              "id": "85885",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020578s053lbl.pdf",
              "date": "20260512",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "19990304",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20150212",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25221",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019726Orig1s059,020578Orig1s037ltr.pdf",
              "date": "20150217",
              "type": "Letter"
            },
            {
              "id": "34876",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019726s059,020578s037lbl.pdf",
              "date": "20150213",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "51",
          "submission_status": "AP",
          "submission_status_date": "20250923",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "83431",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020578Orig1s051ltr.pdf",
              "date": "20250925",
              "type": "Letter"
            },
            {
              "id": "83481",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020578s051lbl.pdf",
              "date": "20250925",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19980918",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20090831",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12761",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf",
              "date": "20090917",
              "type": "Label"
            },
            {
              "id": "2769",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf",
              "date": "20100120",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20130618",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12764",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020578s034,020578s035lbl.pdf",
              "date": "20130617",
              "type": "Label"
            },
            {
              "id": "2772",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019726Orig1s056,s057,020578Orig1s034,s035ltr.pdf",
              "date": "20130620",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19971113",
          "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": "19970609",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "25",
          "submission_status": "AP",
          "submission_status_date": "20051019",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "25219",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020578s025,019726s046ltr.pdf",
              "date": "20051025",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20020205",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "2766",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20578s13ltr.pdf",
              "date": "20020205",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20001016",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "19991103",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "19981207",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "44",
          "submission_status": "AP",
          "submission_status_date": "20210617",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "67851",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020578Orig1s044ltr.pdf",
              "date": "20210622",
              "type": "Letter"
            },
            {
              "id": "79916",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020578s044lbl.pdf",
              "date": "20241021",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20141007",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12765",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019726s058,020578s036lbl.pdf",
              "date": "20141009",
              "type": "Label"
            },
            {
              "id": "2773",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019726Orig1s058,020578Orig1s036ltr.pdf",
              "date": "20141009",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "19980716",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20090831",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "34874",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020578s028s029s030lbl.pdf",
              "date": "20090917",
              "type": "Label"
            },
            {
              "id": "2768",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020578s028,s029,s030ltr.pdf",
              "date": "20100120",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA020578",
      "sponsor_name": "TERSERA",
      "openfda": {
        "application_number": [
          "NDA020578"
        ],
        "brand_name": [
          "ZOLADEX"
        ],
        "generic_name": [
          "GOSERELIN"
        ],
        "manufacturer_name": [
          "TerSera Therapeutics LLC"
        ],
        "product_ndc": [
          "70720-951"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "GOSERELIN ACETATE"
        ],
        "rxcui": [
          "211544",
          "314008"
        ],
        "spl_id": [
          "a7c38eaa-3f9a-4b24-8634-bdac6138f983"
        ],
        "spl_set_id": [
          "e4cb3c20-2738-400a-b522-3f36f71fe6c5"
        ],
        "package_ndc": [
          "70720-951-30"
        ],
        "unii": [
          "6YUU2PV0U8"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ZOLADEX",
          "active_ingredients": [
            {
              "name": "GOSERELIN ACETATE",
              "strength": "EQ 10.8MG BASE"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "IMPLANT",
          "route": "IMPLANTATION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}