{
  "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": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20240425",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        }
      ],
      "application_number": "ANDA218150",
      "sponsor_name": "GLAND",
      "openfda": {
        "application_number": [
          "ANDA218150"
        ],
        "brand_name": [
          "CETRORELIX ACETATE"
        ],
        "generic_name": [
          "CETRORELIX ACETATE"
        ],
        "manufacturer_name": [
          "Gland Pharma Limited",
          "FRESENIUS KABI USA, LLC"
        ],
        "product_ndc": [
          "68083-600",
          "65219-292"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "283402"
        ],
        "spl_id": [
          "ab90e510-eecd-4d5f-b2df-059d3cbfc8f0",
          "96fa0188-c4cd-4e23-b376-457bd6df8e2f"
        ],
        "spl_set_id": [
          "89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a",
          "c9c50fcb-b28d-4085-9116-b38a21d31b99"
        ],
        "package_ndc": [
          "68083-600-01",
          "68083-598-01",
          "68083-599-01",
          "65219-292-77",
          "65219-290-02",
          "65219-286-01"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "CETRORELIX ACETATE",
          "active_ingredients": [
            {
              "name": "CETRORELIX ACETATE",
              "strength": "EQ 0.25MG BASE/VIAL"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "POWDER",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}