{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130125",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 8",
          "submission_class_code_description": "Type 8 - Partial Rx to OTC Switch",
          "application_docs": [
            {
              "id": "19296",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202211Orig1s000lbl.pdf",
              "date": "20131112",
              "type": "Label"
            },
            {
              "id": "22878",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211_oxytrol_toc.html",
              "date": "20131105",
              "type": "Review"
            },
            {
              "id": "24410",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202211Orig1s000SumR.pdf",
              "date": "20131105",
              "type": "Summary Review"
            },
            {
              "id": "32205",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202211Orig1s000ltr.pdf",
              "date": "20130130",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20160303",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "40139",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202211Orig1s004lbl.pdf",
              "date": "20160304",
              "type": "Label"
            },
            {
              "id": "32206",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202211Orig1s004ltr.pdf",
              "date": "20160304",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20130816",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20140515",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20130820",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA202211",
      "sponsor_name": "ABBVIE",
      "openfda": {
        "application_number": [
          "NDA202211"
        ],
        "brand_name": [
          "OXYTROL FOR WOMEN"
        ],
        "generic_name": [
          "OXYBUTYNIN"
        ],
        "manufacturer_name": [
          "Allergan, Inc."
        ],
        "product_ndc": [
          "0023-9637"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "substance_name": [
          "OXYBUTYNIN"
        ],
        "rxcui": [
          "403799",
          "404448"
        ],
        "spl_id": [
          "cc404430-2345-4294-8efc-e1e996cc17b2"
        ],
        "spl_set_id": [
          "8cdc5b4d-ff8d-4010-97d7-313422a0b868"
        ],
        "package_ndc": [
          "0023-9637-04",
          "0023-9637-08"
        ],
        "nui": [
          "N0000175700",
          "N0000000125"
        ],
        "pharm_class_epc": [
          "Cholinergic Muscarinic Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Cholinergic Muscarinic Antagonists [MoA]"
        ],
        "unii": [
          "K9P6MC7092"
        ]
      },
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "OXYTROL FOR WOMEN",
          "active_ingredients": [
            {
              "name": "OXYBUTYNIN",
              "strength": "3.9MG/24HR"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "FILM, EXTENDED RELEASE",
          "route": "TRANSDERMAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}