{ "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": "34", "submission_status": "AP", "submission_status_date": "19841126", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "19890109", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "19820622", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "19841120", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "19830629", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "19810427", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "67", "submission_status": "AP", "submission_status_date": "20010207", "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": "19811214", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "19820622", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "59", "submission_status": "AP", "submission_status_date": "19940818", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "73", "submission_status": "AP", "submission_status_date": "20100604", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11091", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s073lbl.pdf", "date": "20100607", "type": "Label" }, { "id": "13948", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017911s073ltr.pdf", "date": "20100610", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "65", "submission_status": "AP", "submission_status_date": "20061005", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "741", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017911s065ltr.pdf", "date": "20061013", "type": "Letter" }, { "id": "33366", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s065_lbl.pdf", "date": "20061011", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19790808", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "57", "submission_status": "AP", "submission_status_date": "19950601", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "49", "submission_status": "AP", "submission_status_date": "19890206", "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": "19810512", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "63", "submission_status": "AP", "submission_status_date": "19970502", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "55", "submission_status": "AP", "submission_status_date": "19920727", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19790808", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "19890109", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19790814", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "45", "submission_status": "AP", "submission_status_date": "19880503", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "37", "submission_status": "AP", "submission_status_date": "19860205", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "51", "submission_status": "AP", "submission_status_date": "19890531", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "19890109", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "19860205", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "27", "submission_status": "AP", "submission_status_date": "19890531", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "19840726", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "19840813", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "19820629", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "19840126", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "19840529", "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": "19930512", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "68", "submission_status": "AP", "submission_status_date": "20060124", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "742", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017911s068ltr.pdf", "date": "20060130", "type": "Letter" }, { "id": "11089", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017911s068lbl.pdf", "date": "20060125", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "74", "submission_status": "AP", "submission_status_date": "20101223", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "744", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017911s074ltr.pdf", "date": "20101228", "type": "Letter" }, { "id": "33368", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017911s074lbl.pdf", "date": "20101226", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "19810605", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "66", "submission_status": "AP", "submission_status_date": "20011030", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "19811214", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "58", "submission_status": "AP", "submission_status_date": "19950710", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "72", "submission_status": "AP", "submission_status_date": "20090330", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13947", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017911s072ltr.pdf", "date": "20090403", "type": "Letter" }, { "id": "33367", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017911s072lbl.pdf", "date": "20090403", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "19811221", "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": "19791001", "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": "19970414", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "70", "submission_status": "AP", "submission_status_date": "20070823", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "743", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017911s070ltr.pdf", "date": "20070827", "type": "Letter" }, { "id": "11090", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017911s070lbl.pdf", "date": "20070827", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19790806", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "62", "submission_status": "AP", "submission_status_date": "19960301", "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": "19780927", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity", "application_docs": [ { "id": "43601", "url": "http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088573.pdf", "date": "20091116", "type": "Medication Guide" } ] }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "19790723", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "46", "submission_status": "AP", "submission_status_date": "19890109", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "60", "submission_status": "AP", "submission_status_date": "19941024", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "38", "submission_status": "AP", "submission_status_date": "19860205", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "52", "submission_status": "AP", "submission_status_date": "19890531", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "44", "submission_status": "AP", "submission_status_date": "19890109", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "19890109", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" } ], "application_number": "NDA017911", "sponsor_name": "MERCK", "products": [ { "product_number": "001", "reference_drug": "Yes", "brand_name": "CLINORIL", "active_ingredients": [ { "name": "SULINDAC", "strength": "150MG **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": "002", "reference_drug": "Yes", "brand_name": "CLINORIL", "active_ingredients": [ { "name": "SULINDAC", "strength": "200MG **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" } ] } ] }