{
  "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": "2026-08-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "45",
          "submission_status": "AP",
          "submission_status_date": "20250923",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20001025",
          "application_docs": [
            {
              "id": "30899",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75471ltr.pdf",
              "date": "20001025",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20250919",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20170519",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "33",
          "submission_status": "AP",
          "submission_status_date": "20170519",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "48",
          "submission_status": "AP",
          "submission_status_date": "20260506",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20250919",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20170519",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20090527",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20130131",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20120809",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20110328",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20010920",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "ANDA075471",
      "sponsor_name": "MEITHEAL",
      "openfda": {
        "application_number": [
          "ANDA075471"
        ],
        "brand_name": [
          "LEUPROLIDE ACETATE"
        ],
        "generic_name": [
          "LEUPROLIDE ACETATE"
        ],
        "manufacturer_name": [
          "Meitheal Pharmaceuticals Inc"
        ],
        "product_ndc": [
          "71288-569"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "rxcui": [
          "545835",
          "797544"
        ],
        "spl_id": [
          "4fc2b983-6691-4203-90a1-a48e144e4b3d"
        ],
        "spl_set_id": [
          "d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584"
        ],
        "package_ndc": [
          "71288-569-90",
          "71288-565-03",
          "71288-350-91"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "LEUPROLIDE ACETATE",
          "active_ingredients": [
            {
              "name": "LEUPROLIDE ACETATE",
              "strength": "14MG/2.8ML (1MG/0.2ML)"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SOLUTION",
          "route": "SUBCUTANEOUS",
          "marketing_status": "Prescription",
          "te_code": "AP"
        }
      ]
    }
  ]
}