{ "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": "15", "submission_status": "AP", "submission_status_date": "20010517", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "20000615", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "19980318", "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": "20000629", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "19981203", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19980318", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19970919", "review_priority": "STANDARD", "submission_class_code": "TYPE 3", "submission_class_code_description": "Type 3 - New Dosage Form", "application_docs": [ { "id": "41558", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020692s000_SereventTOC.html", "date": "20051206", "type": "Review" }, { "id": "23591", "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm", "date": "20051130", "type": "Other Important Information from FDA" } ] }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "19980925", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "41559", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20692S1,2_Serevent.html", "date": "19980925", "type": "Review" }, { "id": "35144", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf", "date": "19980925", "type": "Label" }, { "id": "3088", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf", "date": "19980925", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "46", "submission_status": "AP", "submission_status_date": "20181221", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "57010", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020692s046lbl.pdf", "date": "20181226", "type": "Label" }, { "id": "57011", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020692s046lbl.pdf#page=34", "date": "20181226", "type": "Medication Guide" }, { "id": "57074", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020692Orig1s046ltr.pdf", "date": "20181231", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "38", "submission_status": "AP", "submission_status_date": "20110510", "review_priority": "N/A", "submission_class_code": "REMS", "submission_class_code_description": "REMS", "application_docs": [ { "id": "43666", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020692s038MedG.pdf", "date": "20110516", "type": "Medication Guide" }, { "id": "25525", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf", "date": "20110512", "type": "Letter" }, { "id": "35148", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf", "date": "20110516", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "44", "submission_status": "AP", "submission_status_date": "20160617", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "20100625", "review_priority": "901 ORDER", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3093", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf", "date": "20100629", "type": "Letter" }, { "id": "35147", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s036lbl.pdf", "date": "20100628", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "20070223", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3090", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028, 021077s027ltr.pdf", "date": "20070301", "type": "Letter" }, { "id": "35146", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020692s028lbl.pdf", "date": "20070226", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "20120809", "review_priority": "N/A", "submission_class_code": "REMS", "submission_class_code_description": "REMS", "application_docs": [ { "id": "25526", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf", "date": "20120813", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "20040928", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25522", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf", "date": "20041004", "type": "Letter" }, { "id": "35145", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20236s030,20692s026lbl.pdf", "date": "20041004", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "20120809", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "20020515", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "20101230", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13216", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s032lbl.pdf", "date": "20110104", "type": "Label" }, { "id": "3092", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s032ltr.pdf", "date": "20110104", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "20030811", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13213", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20692slr024_serevent_lbl.pdf", "date": "20030815", "type": "Label" }, { "id": "20828", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020692_s024_SEREVENT DISKUS.pdf", "date": "20080801", "type": "Review" }, { "id": "25521", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20692slr024ltr.pdf", "date": "20030815", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "20020322", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "13212", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20692s16lbl.pdf", "date": "20020322", "type": "Label" }, { "id": "3089", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20692s016ltr.pdf", "date": "20020322", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "20010119", "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": "20020517", "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": "20000403", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19980311", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "10", "submission_status": "AP", "submission_status_date": "19990720", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "19980521", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19980326", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "20190722", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "59401", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020692s047lbl.pdf", "date": "20190723", "type": "Label" }, { "id": "59402", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020692s047lbl.pdf#page=35", "date": "20190723", "type": "Medication Guide" }, { "id": "59412", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020692Orig1s047ltr.pdf", "date": "20190723", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "39", "submission_status": "AP", "submission_status_date": "20110627", "review_priority": "N/A", "submission_class_code": "REMS", "submission_class_code_description": "REMS", "application_docs": [ { "id": "3094", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf", "date": "20110705", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19980925", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "13211", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf", "date": "19980925", "type": "Label" }, { "id": "20827", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20692S1,2_Serevent.html", "date": "19980925", "type": "Review" }, { "id": "25520", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf", "date": "19980925", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "45", "submission_status": "AP", "submission_status_date": "20160930", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "45475", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020692Orig1s045ltr.pdf", "date": "20161005", "type": "Letter" }, { "id": "45585", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020692s045lbl.pdf", "date": "20161006", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "20060302", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13214", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020692s029lbl.pdf", "date": "20060303", "type": "Label" }, { "id": "3091", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029ltr.pdf", "date": "20060323", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "20140414", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25527", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020692Orig1s043ltr.pdf", "date": "20140416", "type": "Letter" }, { "id": "35149", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020692s043lbl.pdf", "date": "20140416", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "20101118", "review_priority": "N/A", "submission_class_code": "REMS", "submission_class_code_description": "REMS", "application_docs": [ { "id": "25524", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s035ltr.pdf", "date": "20101122", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "20011016", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "20080320", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13215", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf", "date": "20080324", "type": "Label" }, { "id": "25523", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s003,020692s031ltr.pdf", "date": "20080321", "type": "Letter" } ] } ], "application_number": "NDA020692", "sponsor_name": "GLAXOSMITHKLINE", "openfda": { "application_number": [ "NDA020692" ], "brand_name": [ "SEREVENT DISKUS" ], "generic_name": [ "SALMETEROL XINAFOATE" ], "manufacturer_name": [ "GlaxoSmithKline LLC" ], "product_ndc": [ "0173-0521" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "RESPIRATORY (INHALATION)" ], "substance_name": [ "SALMETEROL XINAFOATE" ], "rxcui": [ "866048", "866049" ], "spl_id": [ "5532804f-f5b5-492b-a092-0b1ce60c8de1" ], "spl_set_id": [ "12d9728e-6b5c-4aee-bfb0-745e542ed2e4" ], "package_ndc": [ "0173-0521-00" ], "unii": [ "6EW8Q962A5" ] }, "products": [ { "product_number": "001", "reference_drug": "Yes", "brand_name": "SEREVENT", "active_ingredients": [ { "name": "SALMETEROL XINAFOATE", "strength": "EQ 0.05MG BASE/INH" } ], "reference_standard": "Yes", "dosage_form": "POWDER", "route": "INHALATION", "marketing_status": "Prescription" } ] } ] }