{ "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": "1", "submission_status": "AP", "submission_status_date": "19970728", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "27", "submission_status": "AP", "submission_status_date": "20131015", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12637", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf", "date": "20131022", "type": "Label" }, { "id": "25049", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s027ltr.pdf", "date": "20131018", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "20090203", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12635", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf", "date": "20090204", "type": "Label" }, { "id": "2603", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf", "date": "20090213", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "20130419", "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": "20051128", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "51965", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020496s015_glimepiride_Amaryl_Clinical_BPCA.pdf", "date": "19000101", "type": "Pediatric Medical Review" }, { "id": "51966", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020496_glimepiride_Amaryl_WR.pdf", "date": "19000101", "type": "Pediatric Written Request" }, { "id": "51967", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020496s015_glimepiride_Amaryl-Statistical_BPCA.pdf", "date": "19000101", "type": "Pediatric Statistical Review" }, { "id": "25044", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s015ltr.pdf", "date": "20051206", "type": "Letter" }, { "id": "34709", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf", "date": "20051205", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "20090604", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25046", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s021ltr.pdf", "date": "20090616", "type": "Letter" }, { "id": "34712", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf", "date": "20090604", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "20040816", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25043", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20496s013ltr.pdf", "date": "20040825", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "20010721", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "20000106", "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": "19980916", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "19990224", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "20683", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020496S002.html", "date": "19990224", "type": "Review" }, { "id": "2600", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20496s2ltr.pdf", "date": "19990224", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "20161219", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "46490", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020496Orig1s028ltr.pdf", "date": "20161222", "type": "Letter" }, { "id": "46494", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020496s028lbl.pdf", "date": "20161221", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "20130801", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12636", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf", "date": "20130809", "type": "Label" }, { "id": "25048", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s026ltr.pdf", "date": "20130805", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "20090203", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25045", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf", "date": "20090213", "type": "Letter" }, { "id": "34711", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf", "date": "20090204", "type": "Label" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19951130", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity", "application_docs": [ { "id": "57651", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020496Orig1s000rev.pdf", "date": "20190215", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "20130314", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "20050919", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2602", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s016ltr.pdf", "date": "20050922", "type": "Letter" }, { "id": "34710", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf", "date": "20050922", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "20120203", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25047", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020496s022ltr.pdf", "date": "20120208", "type": "Letter" }, { "id": "34713", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf", "date": "20120206", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "10", "submission_status": "AP", "submission_status_date": "20001205", "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": "20000829", "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": "20020415", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2601", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20496s7ltr.pdf", "date": "20020415", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "20000927", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "20684", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20496-S005_Amaryl.pdf", "date": "20040527", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "20181221", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "57013", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020496s029lbl.pdf", "date": "20181226", "type": "Label" }, { "id": "57073", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020496Orig1s029Ltr.pdf", "date": "20181231", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19980916", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" } ], "application_number": "NDA020496", "sponsor_name": "SANOFI AVENTIS US", "products": [ { "product_number": "002", "reference_drug": "Yes", "brand_name": "AMARYL", "active_ingredients": [ { "name": "GLIMEPIRIDE", "strength": "2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued", "te_code": "AB" }, { "product_number": "003", "reference_drug": "Yes", "brand_name": "AMARYL", "active_ingredients": [ { "name": "GLIMEPIRIDE", "strength": "4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued", "te_code": "AB" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "AMARYL", "active_ingredients": [ { "name": "GLIMEPIRIDE", "strength": "1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued", "te_code": "AB" } ] } ] }