{
  "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": "10",
          "submission_status": "AP",
          "submission_status_date": "20080404",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27042",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021197s010ltr.pdf",
              "date": "20080410",
              "type": "Letter"
            },
            {
              "id": "36324",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf",
              "date": "20080416",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20040430",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4612",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf",
              "date": "20040507",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20001213",
          "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": "20231204",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "77115",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021197Orig1s029ltr.pdf",
              "date": "20231222",
              "type": "Letter"
            },
            {
              "id": "77116",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197Orig1s029lbl.pdf",
              "date": "20231222",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20231218",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77046",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021197Orig1s017, s022ltr.pdf",
              "date": "20231219",
              "type": "Letter"
            },
            {
              "id": "77086",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197s017s022lbl.pdf",
              "date": "20231219",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20130315",
          "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": "20040430",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4613",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf",
              "date": "20040507",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20040430",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27041",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf",
              "date": "20040507",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20000811",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "14622",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf",
              "date": "20000811",
              "type": "Label"
            },
            {
              "id": "21504",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-197_Cetrotide.html",
              "date": "20000811",
              "type": "Review"
            },
            {
              "id": "27040",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21197ltr.pdf",
              "date": "20000811",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20171222",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68282",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021197Orig1s018ltr.pdf",
              "date": "20210804",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20241118",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "80243",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021197Orig1s032ltr.pdf",
              "date": "20241119",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20240604",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "78637",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021197Orig1s030ltr.pdf",
              "date": "20240605",
              "type": "Letter"
            },
            {
              "id": "78642",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021197s030lbl.pdf",
              "date": "20240605",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20231218",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77047",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021197Orig1s017, s022ltr.pdf",
              "date": "20231219",
              "type": "Letter"
            },
            {
              "id": "77087",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021197s017s022lbl.pdf",
              "date": "20231219",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20130313",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20130129",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA021197",
      "sponsor_name": "EMD SERONO INC",
      "openfda": {
        "application_number": [
          "NDA021197"
        ],
        "brand_name": [
          "CETROTIDE"
        ],
        "generic_name": [
          "CETRORELIX ACETATE"
        ],
        "manufacturer_name": [
          "EMD Serono, Inc."
        ],
        "product_ndc": [
          "44087-1225"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "rxcui": [
          "283402",
          "284441"
        ],
        "spl_id": [
          "716029d9-4462-4732-846c-456e74363b83"
        ],
        "spl_set_id": [
          "aca7768e-28a7-4027-b1d8-e66247665f79"
        ],
        "package_ndc": [
          "44087-1225-1"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "CETROTIDE",
          "active_ingredients": [
            {
              "name": "CETRORELIX ACETATE",
              "strength": "EQ 3MG BASE/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "POWDER",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CETROTIDE",
          "active_ingredients": [
            {
              "name": "CETRORELIX ACETATE",
              "strength": "EQ 0.25MG BASE/VIAL"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "POWDER",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}