{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20211019",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69034",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203752s012,s013lbl.pdf",
              "date": "20211020",
              "type": "Label"
            },
            {
              "id": "69044",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203752Orig1s012,s013ltr.pdf",
              "date": "20211021",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20141110",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20140923",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "40324",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203752s004lbl.pdf",
              "date": "20140926",
              "type": "Label"
            },
            {
              "id": "10247",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203752Orig1s004ltr.pdf",
              "date": "20140925",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20121029",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 5",
          "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer",
          "application_docs": [
            {
              "id": "10246",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203752Orig1s000ltr.pdf",
              "date": "20121101",
              "type": "Letter"
            },
            {
              "id": "19491",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203752lbl.pdf",
              "date": "20121029",
              "type": "Label"
            },
            {
              "id": "22934",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203752_minivelle_toc.html",
              "date": "20130328",
              "type": "Review"
            },
            {
              "id": "24447",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203752Orig1s000SumR.pdf",
              "date": "20130328",
              "type": "Summary Review"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20140521",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20211012",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68972",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203752Orig1s016ltr.pdf",
              "date": "20211013",
              "type": "Letter"
            },
            {
              "id": "69955",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203752Orig1s016lbl.pdf",
              "date": "20220124",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20240215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77548",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203752Orig1s022ltr.pdf",
              "date": "20240216",
              "type": "Letter"
            },
            {
              "id": "77573",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203752s022lbl.pdf",
              "date": "20240220",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20171101",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50279",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203752s009lbl.pdf",
              "date": "20171102",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20211019",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69033",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203752s012,s013lbl.pdf",
              "date": "20211020",
              "type": "Label"
            },
            {
              "id": "69043",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203752Orig1s012,s013ltr.pdf",
              "date": "20211021",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20140418",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA203752",
      "sponsor_name": "NOVEN",
      "openfda": {
        "application_number": [
          "NDA203752"
        ],
        "brand_name": [
          "ESTRADIOL",
          "MINIVELLE"
        ],
        "generic_name": [
          "ESTRADIOL"
        ],
        "manufacturer_name": [
          "Noven Therapeutics, LLC"
        ],
        "product_ndc": [
          "68968-3410",
          "68968-3425",
          "68968-3437",
          "68968-3450",
          "68968-3475",
          "68968-6610",
          "68968-6625",
          "68968-6637",
          "68968-6650",
          "68968-6675"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "ESTRADIOL"
        ],
        "rxcui": [
          "241946",
          "242891",
          "242892",
          "248478",
          "1149632",
          "1356979",
          "1356997",
          "1357007",
          "1357009",
          "1551622"
        ],
        "spl_id": [
          "4d2e5c5f-d82f-4a2c-bfa5-2899fb283696",
          "0d1f7ac0-2185-451c-bd3f-0a5a67ef8d54"
        ],
        "spl_set_id": [
          "bf185599-2138-4083-9c52-2b95dce09ae0",
          "6c5c47ab-28ee-11e1-bfc2-0800200c9a66"
        ],
        "package_ndc": [
          "68968-3425-8",
          "68968-3437-8",
          "68968-3450-8",
          "68968-3475-8",
          "68968-3410-8",
          "68968-6625-8",
          "68968-6637-8",
          "68968-6650-8",
          "68968-6675-8",
          "68968-6610-8"
        ],
        "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": "004",
          "reference_drug": "Yes",
          "brand_name": "MINIVELLE",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.1MG/24HR"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "FILM, EXTENDED RELEASE",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription",
          "te_code": "AB3"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "MINIVELLE",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.075MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FILM, EXTENDED RELEASE",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription",
          "te_code": "AB3"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "MINIVELLE",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.025MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FILM, EXTENDED RELEASE",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription",
          "te_code": "AB3"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "MINIVELLE",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.05MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FILM, EXTENDED RELEASE",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription",
          "te_code": "AB3"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "MINIVELLE",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.0375MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FILM, EXTENDED RELEASE",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription",
          "te_code": "AB3"
        }
      ]
    }
  ]
}