{
  "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": "2026-06-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "20131009",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4808",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021258Orig1s006ltr.pdf",
              "date": "20131011",
              "type": "Letter"
            },
            {
              "id": "36489",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021258s006lbl.pdf",
              "date": "20131017",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20211115",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "69315",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021258orig1s012ltr.pdf",
              "date": "20211116",
              "type": "Letter"
            },
            {
              "id": "69326",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021258s012lbl.pdf",
              "date": "20211116",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20160308",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20240215",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "77559",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021258s015lbl.pdf",
              "date": "20240220",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20211007",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68951",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021258Orig1s013ltr.pdf",
              "date": "20211012",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20031121",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 4",
          "submission_class_code_description": "Type 4 - New Combination",
          "application_docs": [
            {
              "id": "4806",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21258ltr.pdf",
              "date": "20031128",
              "type": "Letter"
            },
            {
              "id": "21553",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021258s000_ClimaraTOC.html",
              "date": "20060607",
              "type": "Review"
            },
            {
              "id": "36487",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021258lbl.pdf",
              "date": "20040401",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20171101",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50264",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021258s011lbl.pdf",
              "date": "20171102",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20050622",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4807",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021258s003ltr.pdf",
              "date": "20050624",
              "type": "Letter"
            },
            {
              "id": "36488",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021258s003lbl.pdf",
              "date": "20050624",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA021258",
      "sponsor_name": "BAYER HLTHCARE",
      "openfda": {
        "application_number": [
          "NDA021258"
        ],
        "brand_name": [
          "CLIMARA PRO"
        ],
        "generic_name": [
          "ESTRADIOL AND LEVONORGESTREL"
        ],
        "manufacturer_name": [
          "Bayer HealthCare Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "50419-491"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "ESTRADIOL",
          "LEVONORGESTREL"
        ],
        "rxcui": [
          "402250",
          "402252"
        ],
        "spl_id": [
          "9f4e7765-d4e7-4f36-9530-8b4444587214"
        ],
        "spl_set_id": [
          "184d3092-7fc6-4375-816b-1ab06bb99cfd"
        ],
        "package_ndc": [
          "50419-491-04",
          "50419-491-73"
        ],
        "nui": [
          "M0447348",
          "N0000175825",
          "N0000000100",
          "N0000175830",
          "M0447349",
          "N0000175602",
          "N0000175832"
        ],
        "pharm_class_cs": [
          "Estradiol Congeners [CS]",
          "Progesterone Congeners [CS]"
        ],
        "pharm_class_epc": [
          "Estrogen [EPC]",
          "Progestin [EPC]",
          "Progestin-containing Intrauterine System [EPC]"
        ],
        "pharm_class_moa": [
          "Estrogen Receptor Agonists [MoA]"
        ],
        "pharm_class_pe": [
          "Inhibit Ovum Fertilization [PE]"
        ],
        "unii": [
          "4TI98Z838E",
          "5W7SIA7YZW"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "CLIMARA PRO",
          "active_ingredients": [
            {
              "name": "ESTRADIOL",
              "strength": "0.045MG/24HR"
            },
            {
              "name": "LEVONORGESTREL",
              "strength": "0.015MG/24HR"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "FILM, EXTENDED RELEASE",
          "route": "TRANSDERMAL",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}