{
  "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": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20210712",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68077",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022008Orig1s012, s013ltr.pdf",
              "date": "20210714",
              "type": "Letter"
            },
            {
              "id": "68104",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022008s012s013lbl.pdf",
              "date": "20210716",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "8",
          "submission_status": "AP",
          "submission_status_date": "20140828",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38074",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf",
              "date": "20140903",
              "type": "Label"
            },
            {
              "id": "29063",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf",
              "date": "20140902",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20140828",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6672",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf",
              "date": "20140902",
              "type": "Letter"
            },
            {
              "id": "16756",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf",
              "date": "20140903",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20090410",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "16755",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022008s002lbl.pdf",
              "date": "20090416",
              "type": "Label"
            },
            {
              "id": "29061",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022008s002ltr.pdf",
              "date": "20090416",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20080613",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "16753",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008lbl.pdf",
              "date": "20080709",
              "type": "Label"
            },
            {
              "id": "21903",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022008_requip_toc.html",
              "date": "20081229",
              "type": "Review"
            },
            {
              "id": "29059",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s000ltr.pdf",
              "date": "20080620",
              "type": "Letter"
            },
            {
              "id": "29060",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s000ltr_FINAL.pdf",
              "date": "20080708",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20210712",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68076",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022008Orig1s012, s013ltr.pdf",
              "date": "20210714",
              "type": "Letter"
            },
            {
              "id": "68103",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022008s012s013lbl.pdf",
              "date": "20210716",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20170323",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "47663",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022008Orig1s009ltr.pdf",
              "date": "20170324",
              "type": "Letter"
            },
            {
              "id": "47699",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022008s009lbl.pdf",
              "date": "20170324",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20140828",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "6673",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf",
              "date": "20140902",
              "type": "Letter"
            },
            {
              "id": "16757",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf",
              "date": "20140903",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20140828",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "38073",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf",
              "date": "20140903",
              "type": "Label"
            },
            {
              "id": "29062",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf",
              "date": "20140902",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20081031",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "6671",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s001ltr.pdf",
              "date": "20081103",
              "type": "Letter"
            },
            {
              "id": "16754",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008s001lbl.pdf",
              "date": "20081107",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA022008",
      "sponsor_name": "GLAXOSMITHKLINE LLC",
      "products": [
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "REQUIP XL",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "REQUIP XL",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "REQUIP XL",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "REQUIP XL",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "REQUIP XL",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "REQUIP XL",
          "active_ingredients": [
            {
              "name": "ROPINIROLE HYDROCHLORIDE",
              "strength": "EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}