{
  "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": "2026-07-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20050408",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "26895",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s005ltr.pdf",
              "date": "20050412",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20050209",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "26893",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s001,003ltr.pdf",
              "date": "20050211",
              "type": "Letter"
            },
            {
              "id": "36207",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21144s001,003lbl.pdf",
              "date": "20050211",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20050209",
          "review_priority": "UNKNOWN",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "4453",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21144s001,003ltr.pdf",
              "date": "20050211",
              "type": "Letter"
            },
            {
              "id": "36206",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21144s001,003lbl.pdf",
              "date": "20050211",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20151104",
          "submission_public_notes": "Please see <a href=\"https://www.fda.gov/STIC/\">www.fda.gov/STIC</a> for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4458",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021144Orig1s019ltr.pdf",
              "date": "20151109",
              "type": "Letter"
            },
            {
              "id": "56369",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf#page=29",
              "date": "20181108",
              "type": "Medication Guide"
            },
            {
              "id": "14492",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s019lbl.pdf",
              "date": "20151112",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20140226",
          "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": "20110620",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "4457",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021144s015ltr.pdf",
              "date": "20110629",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20101208",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36209",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s013lbl.pdf",
              "date": "20101208",
              "type": "Label"
            },
            {
              "id": "26896",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021144s013,s014ltr.pdf",
              "date": "20101210",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "20060629",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4454",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021144s011ltr.pdf",
              "date": "20060703",
              "type": "Letter"
            },
            {
              "id": "14489",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021144s011lbl.pdf",
              "date": "20060703",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20051102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "26894",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021144s004ltr.pdf",
              "date": "20051108",
              "type": "Letter"
            },
            {
              "id": "36208",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021144s004lbl.pdf",
              "date": "20051103",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20150309",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "26897",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021144Orig1s018ltr.pdf",
              "date": "20150327",
              "type": "Letter"
            },
            {
              "id": "36210",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021144s018lbl.pdf",
              "date": "20150327",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20040401",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 1",
          "submission_class_code_description": "Type 1 - New Molecular Entity",
          "application_docs": [
            {
              "id": "41981",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-144_Ketek.html",
              "date": "20040708",
              "type": "Review"
            },
            {
              "id": "43713",
              "url": "http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088615.pdf",
              "date": "20091119",
              "type": "Medication Guide"
            },
            {
              "id": "4452",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21144ltr.pdf",
              "date": "20040407",
              "type": "Letter"
            },
            {
              "id": "14488",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21144_ketek_lbl.pdf",
              "date": "20040405",
              "type": "Label"
            },
            {
              "id": "23628",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107824.htm",
              "date": "20040713",
              "type": "Other Important Information from FDA"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20130711",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "14",
          "submission_status": "AP",
          "submission_status_date": "20101208",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4456",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021144s013,s014ltr.pdf",
              "date": "20101210",
              "type": "Letter"
            },
            {
              "id": "14491",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021144s014lbl.pdf",
              "date": "20101209",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20070212",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4455",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021144s012ltr.pdf",
              "date": "20070223",
              "type": "Letter"
            },
            {
              "id": "14490",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021144s012lbl.pdf",
              "date": "20070212",
              "type": "Label"
            },
            {
              "id": "21473",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021144Orig1s012Approv.pdf",
              "date": "20120214",
              "type": "Review"
            }
          ]
        }
      ],
      "application_number": "NDA021144",
      "sponsor_name": "SANOFI AVENTIS US",
      "products": [
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "KETEK",
          "active_ingredients": [
            {
              "name": "TELITHROMYCIN",
              "strength": "300MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "KETEK",
          "active_ingredients": [
            {
              "name": "TELITHROMYCIN",
              "strength": "400MG"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "TABLET",
          "route": "ORAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}