{
  "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": "2026-05-19",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "26",
          "submission_status": "AP",
          "submission_status_date": "20170228",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "47457",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021254Orig1s026ltr.pdf",
              "date": "20170303",
              "type": "Letter"
            },
            {
              "id": "47492",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s026lbl.pdf",
              "date": "20170308",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "20080731",
          "review_priority": "N/A",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "4794",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s004ltr.pdf",
              "date": "20080805",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "18",
          "submission_status": "AP",
          "submission_status_date": "20120809",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "24",
          "submission_status": "AP",
          "submission_status_date": "20141210",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4798",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021254Orig1s024ltr.pdf",
              "date": "20141212",
              "type": "Letter"
            },
            {
              "id": "36480",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s024lbl.pdf",
              "date": "20141211",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "16",
          "submission_status": "AP",
          "submission_status_date": "20110627",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "27231",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf",
              "date": "20110705",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "22",
          "submission_status": "AP",
          "submission_status_date": "20140617",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "20",
          "submission_status": "AP",
          "submission_status_date": "20130619",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "12",
          "submission_status": "AP",
          "submission_status_date": "20110104",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "27228",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021254s012ltr.pdf",
              "date": "20110107",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "20060608",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form",
          "application_docs": [
            {
              "id": "4792",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021254s000LTR.pdf",
              "date": "20060614",
              "type": "Letter"
            },
            {
              "id": "21551",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021254s000TOC.html",
              "date": "20080506",
              "type": "Review"
            },
            {
              "id": "23639",
              "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm",
              "date": "20060619",
              "type": "Other Important Information from FDA"
            },
            {
              "id": "36475",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021254lbl.pdf",
              "date": "20060614",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "20121219",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "51119",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021254_fluticasone-salmeterol_clinical_prea.pdf",
              "date": "19000101",
              "type": "Pediatric Medical Review"
            },
            {
              "id": "51120",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021254_fluticasone-salmeterol_clinpharm_prea.pdf",
              "date": "19000101",
              "type": "Pediatric Clinical Pharmacology Review"
            },
            {
              "id": "51121",
              "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021254_fluticasone-salmeterol_statistical_prea.pdf",
              "date": "19000101",
              "type": "Pediatric Statistical Review"
            },
            {
              "id": "14761",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021254s009lbl.pdf",
              "date": "20121221",
              "type": "Label"
            },
            {
              "id": "27227",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021254Orig1s009ltr.pdf",
              "date": "20121221",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "20090915",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "4795",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021254s007ltr.pdf",
              "date": "20091026",
              "type": "Letter"
            },
            {
              "id": "36477",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021254s007lbl.pdf",
              "date": "20090921",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "27",
          "submission_status": "AP",
          "submission_status_date": "20171220",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "50841",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021254s027lbl.pdf",
              "date": "20171222",
              "type": "Label"
            },
            {
              "id": "50875",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021254Orig1s027ltr.pdf",
              "date": "20171227",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "19",
          "submission_status": "AP",
          "submission_status_date": "20120809",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "4796",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf",
              "date": "20120813",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "20080320",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36476",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf",
              "date": "20080324",
              "type": "Label"
            },
            {
              "id": "4793",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s003,020692s031ltr.pdf",
              "date": "20080321",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "23",
          "submission_status": "AP",
          "submission_status_date": "20141113",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "36479",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s023lbl.pdf",
              "date": "20141220",
              "type": "Label"
            },
            {
              "id": "4797",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021254Orig1s023ltr.pdf",
              "date": "20141114",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "20110510",
          "review_priority": "N/A",
          "submission_class_code": "REMS",
          "submission_class_code_description": "REMS",
          "application_docs": [
            {
              "id": "27230",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf",
              "date": "20110512",
              "type": "Letter"
            },
            {
              "id": "36478",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf",
              "date": "20110516",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20140617",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "20100625",
          "review_priority": "901 ORDER",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "14762",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021254s013lbl.pdf",
              "date": "20100628",
              "type": "Label"
            },
            {
              "id": "27229",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf",
              "date": "20100629",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20210818",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "68408",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021254Orig1s036ltr.pdf",
              "date": "20210819",
              "type": "Letter"
            },
            {
              "id": "68420",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021254s036lbl.pdf",
              "date": "20210819",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20190107",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57131",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021254s028lbl.pdf",
              "date": "20190108",
              "type": "Label"
            },
            {
              "id": "57518",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021254Orig1s028ltr.pdf",
              "date": "20190213",
              "type": "Letter"
            }
          ]
        }
      ],
      "application_number": "NDA021254",
      "sponsor_name": "GLAXO GRP LTD",
      "openfda": {
        "application_number": [
          "NDA021254"
        ],
        "brand_name": [
          "ADVAIR HFA",
          "FLUTICASONE PROPIONATE AND SALMETEROL HFA"
        ],
        "generic_name": [
          "FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE"
        ],
        "manufacturer_name": [
          "GlaxoSmithKline LLC",
          "Prasco Laboratories"
        ],
        "product_ndc": [
          "0173-0715",
          "0173-0716",
          "0173-0717",
          "66993-086",
          "66993-087",
          "66993-088"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RESPIRATORY (INHALATION)"
        ],
        "substance_name": [
          "FLUTICASONE PROPIONATE",
          "SALMETEROL XINAFOATE"
        ],
        "spl_id": [
          "bea52e57-aa75-4dce-8cfb-a163bbc22be2",
          "7a85b8b8-7336-4563-9cf7-a03693e08f70"
        ],
        "spl_set_id": [
          "dfaca6f9-3277-47b2-319d-1377917cb54c",
          "666c5b12-a4f7-4c53-8261-4742b5e5a6df"
        ],
        "package_ndc": [
          "0173-0715-20",
          "0173-0715-22",
          "0173-0716-20",
          "0173-0716-22",
          "0173-0717-20",
          "0173-0717-22",
          "66993-086-96",
          "66993-087-96",
          "66993-088-96"
        ],
        "unii": [
          "6EW8Q962A5",
          "O2GMZ0LF5W"
        ],
        "rxcui": [
          "896236",
          "896244",
          "896272"
        ]
      },
      "products": [
        {
          "product_number": "002",
          "reference_drug": "Yes",
          "brand_name": "ADVAIR HFA",
          "active_ingredients": [
            {
              "name": "FLUTICASONE PROPIONATE",
              "strength": "0.115MG/INH"
            },
            {
              "name": "SALMETEROL XINAFOATE",
              "strength": "EQ 0.021MG BASE/INH"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "AEROSOL, METERED",
          "route": "INHALATION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "003",
          "reference_drug": "Yes",
          "brand_name": "ADVAIR HFA",
          "active_ingredients": [
            {
              "name": "FLUTICASONE PROPIONATE",
              "strength": "0.23MG/INH"
            },
            {
              "name": "SALMETEROL XINAFOATE",
              "strength": "EQ 0.021MG BASE/INH"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "AEROSOL, METERED",
          "route": "INHALATION",
          "marketing_status": "Prescription"
        },
        {
          "product_number": "001",
          "reference_drug": "Yes",
          "brand_name": "ADVAIR HFA",
          "active_ingredients": [
            {
              "name": "FLUTICASONE PROPIONATE",
              "strength": "0.045MG/INH"
            },
            {
              "name": "SALMETEROL XINAFOATE",
              "strength": "EQ 0.021MG BASE/INH"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "AEROSOL, METERED",
          "route": "INHALATION",
          "marketing_status": "Prescription"
        }
      ]
    }
  ]
}