{
  "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": "6",
          "submission_status": "AP",
          "submission_status_date": "20141023",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "40128",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf",
              "date": "20141118",
              "type": "Label"
            },
            {
              "id": "9971",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf",
              "date": "20141027",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20141023",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "40127",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf",
              "date": "20141118",
              "type": "Label"
            },
            {
              "id": "52421",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202129 ciclesonide clinical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "53035",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202129 ciclesonide clinpharm prea.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "53036",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/202129 ciclesonide statistical prea.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "9970",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf",
              "date": "20141027",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "2",
          "submission_status": "AP",
          "submission_status_date": "20140131",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20230216",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "73547",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202129Orig1s009ltr.pdf",
              "date": "20230217",
              "type": "Letter"
            },
            {
              "id": "73552",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202129s009lbl.pdf",
              "date": "20230217",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20120120",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "40126",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202129s000lbl.pdf",
              "date": "20120124",
              "type": "Label"
            },
            {
              "id": "44846",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202129Orig1s000SumR.pdf",
              "date": "20121105",
              "type": "Summary Review"
            },
            {
              "id": "22872",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202129_zetonna_toc.html",
              "date": "20121105",
              "type": "Review"
            },
            {
              "id": "32188",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202129s000ltr.pdf",
              "date": "20120125",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "5",
          "submission_status": "AP",
          "submission_status_date": "20141023",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "19069",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf",
              "date": "20141118",
              "type": "Label"
            },
            {
              "id": "32189",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf",
              "date": "20141027",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20140422",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20121220",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        }
      ],
      "application_number": "NDA202129",
      "sponsor_name": "AZURITY",
      "products": [
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ZETONNA",
          "active_ingredients": [
            {
              "name": "CICLESONIDE",
              "strength": "0.037MG/INH"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "AEROSOL, METERED",
          "route": "NASAL",
          "marketing_status": "Discontinued"
        }
      ]
    }
  ]
}