{
  "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": "2026-10-23",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20190205",
          "review_priority": "STANDARD",
          "submission_class_code": "UNKNOWN"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20240826",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20231116",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        }
      ],
      "application_number": "ANDA211293",
      "sponsor_name": "AMNEAL",
      "openfda": {
        "application_number": [
          "ANDA211293"
        ],
        "brand_name": [
          "DOTTI",
          "ESTRADIOL"
        ],
        "generic_name": [
          "ESTRADIOL"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals LLC",
          "Amneal Pharmaceuticals NY LLC"
        ],
        "product_ndc": [
          "65162-989",
          "65162-992",
          "65162-993",
          "65162-995",
          "65162-997",
          "69238-1629",
          "69238-1630",
          "69238-1631",
          "69238-1632",
          "69238-1633"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "ESTRADIOL"
        ],
        "rxcui": [
          "241946",
          "242891",
          "242892",
          "248478",
          "1149632",
          "2110774",
          "2110777",
          "2110780",
          "2110783",
          "2110786"
        ],
        "spl_id": [
          "d26f45d5-79c5-429a-bb0f-44c58fa0b569",
          "8c947a6b-764e-480e-889c-6576b5cf7708"
        ],
        "spl_set_id": [
          "53016d30-6b5f-49da-ac16-85ef415a5805",
          "0500ee9b-bf4a-4432-9afe-20a7d60a6fe5"
        ],
        "package_ndc": [
          "65162-989-04",
          "65162-989-08",
          "65162-992-04",
          "65162-992-08",
          "65162-993-04",
          "65162-993-08",
          "65162-995-04",
          "65162-995-08",
          "65162-997-04",
          "65162-997-08",
          "69238-1630-1",
          "69238-1630-7",
          "69238-1631-1",
          "69238-1631-7",
          "69238-1632-1",
          "69238-1632-7",
          "69238-1633-1",
          "69238-1633-7",
          "69238-1629-1",
          "69238-1629-7"
        ],
        "nui": [
          "M0447348",
          "N0000175825",
          "N0000000100"
        ],
        "pharm_class_cs": [
          "Estradiol Congeners [CS]"
        ],
        "pharm_class_epc": [
          "Estrogen [EPC]"
        ],
        "pharm_class_moa": [
          "Estrogen Receptor Agonists [MoA]"
        ],
        "unii": [
          "4TI98Z838E"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "ESTRADIOL",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.025MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SYSTEM",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription",
          "te_code": "AB1"
        },
        {
          "product_number": "004",
          "reference_drug": "No",
          "brand_name": "ESTRADIOL",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.075MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SYSTEM",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription",
          "te_code": "AB1"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "ESTRADIOL",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.0375MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SYSTEM",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription",
          "te_code": "AB1"
        },
        {
          "product_number": "005",
          "reference_drug": "No",
          "brand_name": "ESTRADIOL",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.1MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SYSTEM",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription",
          "te_code": "AB1"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "ESTRADIOL",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.05MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "SYSTEM",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription",
          "te_code": "AB1"
        }
      ]
    }
  ]
}