{
  "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": "12",
          "submission_status": "AP",
          "submission_status_date": "20130909",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "20110413",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "15414",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021416s010lbl.pdf",
              "date": "20110415",
              "type": "Label"
            },
            {
              "id": "27724",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021416s010ltr.pdf",
              "date": "20110419",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20030904",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "42144",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-416_Rythmol.html",
              "date": "20040211",
              "type": "Review"
            },
            {
              "id": "5307",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21416ltr.pdf",
              "date": "20030925",
              "type": "Letter"
            },
            {
              "id": "36865",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21416_rythmol_lbl.pdf",
              "date": "20030925",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20101029",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27723",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021416s007ltr.pdf",
              "date": "20101103",
              "type": "Letter"
            },
            {
              "id": "36866",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021416s007lbl.pdf",
              "date": "20101029",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20040913",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "27722",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21416s001ltr.pdf",
              "date": "20040915",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20181102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "56253",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021416s015lbl.pdf",
              "date": "20181102",
              "type": "Label"
            },
            {
              "id": "56329",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021416Orig1s015Ltr.pdf",
              "date": "20181107",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20140711",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20130214",
          "review_priority": "UNKNOWN",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "15415",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021416s011lbl.pdf",
              "date": "20140623",
              "type": "Label"
            }
          ]
        }
      ],
      "application_number": "NDA021416",
      "sponsor_name": "GLAXOSMITHKLINE LLC",
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "RYTHMOL SR",
          "active_ingredients": [
            {
              "name": "PROPAFENONE HYDROCHLORIDE",
              "strength": "325MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued",
          "te_code": "AB"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "RYTHMOL SR",
          "active_ingredients": [
            {
              "name": "PROPAFENONE HYDROCHLORIDE",
              "strength": "425MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued",
          "te_code": "AB"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "RYTHMOL SR",
          "active_ingredients": [
            {
              "name": "PROPAFENONE HYDROCHLORIDE",
              "strength": "225MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "CAPSULE, EXTENDED RELEASE",
          "route": "ORAL",
          "marketing_status": "Discontinued",
          "te_code": "AB"
        }
      ]
    }
  ]
}