{
  "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": "2026-08-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20190503",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20050615",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "39588",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/085470s015lbl.pdf",
              "date": "20090930",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20020528",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19820701",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20000405",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "19980601",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19790815"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20240221",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19820701",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "ANDA085470",
      "sponsor_name": "PFIZER",
      "openfda": {
        "application_number": [
          "ANDA085470"
        ],
        "brand_name": [
          "DEPO-ESTRADIOL"
        ],
        "generic_name": [
          "ESTRADIOL CYPIONATE"
        ],
        "manufacturer_name": [
          "Pharmacia & Upjohn Company LLC"
        ],
        "product_ndc": [
          "0009-0271"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "ESTRADIOL CYPIONATE"
        ],
        "rxcui": [
          "206417",
          "310187"
        ],
        "spl_id": [
          "70957ffe-7710-4a3a-98fa-bf5d84f38ddb"
        ],
        "spl_set_id": [
          "9a4229fd-fecd-4ac1-9c4f-6d442533457f"
        ],
        "package_ndc": [
          "0009-0271-01"
        ],
        "unii": [
          "7E1DV054LO"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "DEPO-ESTRADIOL",
          "active_ingredients": [
            {
              "name": "ESTRADIOL CYPIONATE",
              "strength": "3MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "DEPO-ESTRADIOL",
          "active_ingredients": [
            {
              "name": "ESTRADIOL CYPIONATE",
              "strength": "5MG/ML"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "DEPO-ESTRADIOL",
          "active_ingredients": [
            {
              "name": "ESTRADIOL CYPIONATE",
              "strength": "1MG/ML"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "INJECTABLE",
          "route": "INJECTION",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}