{
  "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": "36",
          "submission_status": "AP",
          "submission_status_date": "20131211",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "34",
          "submission_status": "AP",
          "submission_status_date": "20130405",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20121210",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20150930",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "32",
          "submission_status": "AP",
          "submission_status_date": "20130208",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "30",
          "submission_status": "AP",
          "submission_status_date": "20130131",
          "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": "20100602",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4472",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021149s020ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            },
            {
              "id": "14504",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021149s020lbl.pdf",
              "date": "20200323",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20020515",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20141211",
          "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": "20131219",
          "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": "20130115",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20130411",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20130131",
          "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": "20121213",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20130709",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "31",
          "submission_status": "AP",
          "submission_status_date": "20130115",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20000920",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "41985",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-149_Ovidrel.html",
              "date": "20200323",
              "type": "Review"
            },
            {
              "id": "4471",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21149ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            },
            {
              "id": "14502",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21149lbl.pdf",
              "date": "20200323",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20030714",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "26907",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21149slr006ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20070730",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14503",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021149s013ltr.pdf",
              "date": "20200323",
              "type": "Letter"
            },
            {
              "id": "26908",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021149s013lbl.pdf",
              "date": "20200323",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "BLA021149",
      "sponsor_name": "EMD SERONO",
      "openfda": {
        "application_number": [
          "BLA021149"
        ],
        "brand_name": [
          "OVIDREL"
        ],
        "generic_name": [
          "CHORIOGONADOTROPIN ALFA"
        ],
        "manufacturer_name": [
          "EMD Serono, Inc."
        ],
        "product_ndc": [
          "44087-1150"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "CHORIOGONADOTROPIN ALFA"
        ],
        "rxcui": [
          "727505",
          "727507"
        ],
        "spl_id": [
          "59d39f88-54fb-480a-979b-4d3d2c7c2cd4"
        ],
        "spl_set_id": [
          "a683e58a-63ea-44b8-a326-1a99a537bcf2"
        ],
        "package_ndc": [
          "44087-1150-1"
        ],
        "nui": [
          "N0000175838",
          "M0009540"
        ],
        "pharm_class_epc": [
          "Gonadotropin [EPC]"
        ],
        "pharm_class_cs": [
          "Gonadotropins [CS]"
        ],
        "unii": [
          "6413W06WR3"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "OVIDREL",
          "active_ingredients": [
            {
              "name": "CHORIOGONADOTROPIN ALFA",
              "strength": "0.25MG/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "OVIDREL",
          "active_ingredients": [
            {
              "name": "CHORIOGONADOTROPIN ALFA",
              "strength": "EQ 0.25MG /0.5ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}