{ "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": "2026-06-12", "results": { "skip": 0, "limit": 1, "total": 21 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "54", "submission_status": "AP", "submission_status_date": "19850225", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "60", "submission_status": "AP", "submission_status_date": "19870706", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "99", "submission_status": "AP", "submission_status_date": "20020503", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11870", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s099ltr.pdf", "date": "20020503", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "102", "submission_status": "AP", "submission_status_date": "20061004", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "10721", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf", "date": "20061005", "type": "Label" }, { "id": "11871", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/009218s102LTR.pdf", "date": "20061005", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "52", "submission_status": "AP", "submission_status_date": "19850117", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "97", "submission_status": "AP", "submission_status_date": "20000217", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20020", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/09218S097_Coumadin.pdf", "date": "20000217", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "19780414", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "89", "submission_status": "AP", "submission_status_date": "19980416", "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": "19540608", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity" }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "19801229", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "95", "submission_status": "AP", "submission_status_date": "19991202", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "87", "submission_status": "AP", "submission_status_date": "19981123", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "79", "submission_status": "AP", "submission_status_date": "19950308", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "93", "submission_status": "AP", "submission_status_date": "19981223", "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": "19760927", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "85", "submission_status": "AP", "submission_status_date": "19960905", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "77", "submission_status": "AP", "submission_status_date": "19950207", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "91", "submission_status": "AP", "submission_status_date": "19980601", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "40657", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf", "date": "19980601", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "69", "submission_status": "AP", "submission_status_date": "19931215", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "83", "submission_status": "AP", "submission_status_date": "19961118", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "75", "submission_status": "AP", "submission_status_date": "19930806", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "117", "submission_status": "AP", "submission_status_date": "20170522", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "48516", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf", "date": "20170524", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "67", "submission_status": "AP", "submission_status_date": "19910411", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "59", "submission_status": "AP", "submission_status_date": "19860708", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "73", "submission_status": "AP", "submission_status_date": "19930608", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "115", "submission_status": "AP", "submission_status_date": "20151028", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "10723", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf", "date": "20151029", "type": "Label" }, { "id": "183", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009218Orig1s115ltr.pdf", "date": "20151030", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "65", "submission_status": "AP", "submission_status_date": "19900425", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "107", "submission_status": "AP", "submission_status_date": "20111004", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "182", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009218s107ltr.pdf", "date": "20111005", "type": "Letter" }, { "id": "32995", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf", "date": "20111005", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "71", "submission_status": "AP", "submission_status_date": "19920820", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "113", "submission_status": "AP", "submission_status_date": "20130325", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "63", "submission_status": "AP", "submission_status_date": "19900301", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "105", "submission_status": "AP", "submission_status_date": "20070816", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "181", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009218s105ltr.pdf", "date": "20070817", "type": "Letter" }, { "id": "32994", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009218s105lblv2.pdf", "date": "20070816", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "61", "submission_status": "AP", "submission_status_date": "19880701", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "39", "submission_status": "AP", "submission_status_date": "19800430", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "98", "submission_status": "AP", "submission_status_date": "20020503", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "179", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s098ltr.pdf", "date": "20020503", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "101", "submission_status": "AP", "submission_status_date": "20050902", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "40658", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/009218_s101_coumadin.pdf", "date": "20050902", "type": "Review" }, { "id": "180", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/009218s101ltr.pdf", "date": "20050907", "type": "Letter" }, { "id": "32993", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/009218s101lbl.pdf", "date": "20050907", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "37", "submission_status": "AP", "submission_status_date": "19790706", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "51", "submission_status": "AP", "submission_status_date": "19870706", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "96", "submission_status": "AP", "submission_status_date": "19990709", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "19771205", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "88", "submission_status": "AP", "submission_status_date": "19971029", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "19800201", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "94", "submission_status": "AP", "submission_status_date": "19990331", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "19770211", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "86", "submission_status": "AP", "submission_status_date": "19980601", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20019", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf", "date": "19980601", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "78", "submission_status": "AP", "submission_status_date": "19950207", "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": "19750821", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "84", "submission_status": "AP", "submission_status_date": "19961108", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "76", "submission_status": "AP", "submission_status_date": "19950428", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "90", "submission_status": "AP", "submission_status_date": "19980601", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "40656", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf", "date": "19980601", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "118", "submission_status": "AP", "submission_status_date": "20170814", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "49429", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf", "date": "20170816", "type": "Label" }, { "id": "49486", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009218Orig1s118ltr.pdf", "date": "20170821", "type": "Letter" }, { "id": "56240", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf#page=30", "date": "20181101", "type": "Medication Guide" } ] }, { "submission_type": "SUPPL", "submission_number": "68", "submission_status": "AP", "submission_status_date": "19910411", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "74", "submission_status": "AP", "submission_status_date": "19940331", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "116", "submission_status": "AP", "submission_status_date": "20160908", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "45265", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009218s116lbl.pdf", "date": "20160909", "type": "Label" }, { "id": "45278", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009218Orig1s116ltr.pdf", "date": "20160912", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "66", "submission_status": "AP", "submission_status_date": "19910510", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "80", "submission_status": "AP", "submission_status_date": "19950907", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "108", "submission_status": "AP", "submission_status_date": "20100122", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "10722", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf", "date": "20100124", "type": "Label" }, { "id": "11872", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009218s108ltr.pdf", "date": "20100128", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "72", "submission_status": "AP", "submission_status_date": "19930201", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "114", "submission_status": "AP", "submission_status_date": "20141202", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "64", "submission_status": "AP", "submission_status_date": "19900301", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "56", "submission_status": "AP", "submission_status_date": "19850513", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "70", "submission_status": "AP", "submission_status_date": "19930824", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "62", "submission_status": "AP", "submission_status_date": "19900301", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" } ], "application_number": "NDA009218", "sponsor_name": "BRISTOL MYERS SQUIBB", "products": [ { "product_number": "025", "reference_drug": "Yes", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "3MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" }, { "product_number": "023", "reference_drug": "Yes", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "4MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" }, { "product_number": "007", "reference_drug": "Yes", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "5MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" }, { "product_number": "013", "reference_drug": "Yes", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "2MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" }, { "product_number": "005", "reference_drug": "Yes", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "10MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" }, { "product_number": "026", "reference_drug": "Yes", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "6MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" }, { "product_number": "018", "reference_drug": "Yes", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "2.5MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" }, { "product_number": "024", "reference_drug": "No", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "5MG/VIAL" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Discontinued" }, { "product_number": "016", "reference_drug": "Yes", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "7.5MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" }, { "product_number": "022", "reference_drug": "Yes", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "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" }, { "product_number": "020", "reference_drug": "No", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "50MG/VIAL" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Discontinued" }, { "product_number": "012", "reference_drug": "No", "brand_name": "COUMADIN", "active_ingredients": [ { "name": "WARFARIN SODIUM", "strength": "75MG/VIAL" } ], "reference_standard": "No", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Discontinued" } ] } ] }