{ "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": "101", "submission_status": "AP", "submission_status_date": "20240319", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "78395", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/013263Orig1s101ltr.pdf", "date": "20240506", "type": "Letter" }, { "id": "78398", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/013263Orig1s101lbl.pdf", "date": "20240506", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "59", "submission_status": "AP", "submission_status_date": "19821018", "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": "19881108", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "65", "submission_status": "AP", "submission_status_date": "19830120", "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": "19820811", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "71", "submission_status": "AP", "submission_status_date": "19880120", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "49", "submission_status": "AP", "submission_status_date": "19800519", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "63", "submission_status": "AP", "submission_status_date": "19821130", "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": "19830304", "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": "19790920", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "61", "submission_status": "AP", "submission_status_date": "19821018", "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": "19760827", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "53", "submission_status": "AP", "submission_status_date": "19810717", "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": "19790404", "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": "20230314", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "73782", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s098lbl.pdf", "date": "20230317", "type": "Label" }, { "id": "73783", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/013263Orig1s098ltr.pdf", "date": "20230317", "type": "Letter" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19631115", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity" }, { "submission_type": "SUPPL", "submission_number": "37", "submission_status": "AP", "submission_status_date": "19750618", "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": "19801014", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "19780330", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "96", "submission_status": "AP", "submission_status_date": "20210205", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "66137", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/013263Orig1s096ltr.pdf", "date": "20210209", "type": "Letter" }, { "id": "66203", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/013263s096lbl.pdf", "date": "20210212", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "19761214", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "94", "submission_status": "AP", "submission_status_date": "20161216", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "46318", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/013263s094lbl.pdf", "date": "20161220", "type": "Label" }, { "id": "46457", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/013263Orig1s094ltr.pdf", "date": "20161222", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "86", "submission_status": "AP", "submission_status_date": "20020212", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "40690", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S086_VALIUM_AP.pdf", "date": "20070709", "type": "Review" }, { "id": "359", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/13263s86ltr.pdf", "date": "20020212", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "78", "submission_status": "AP", "submission_status_date": "19970919", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "92", "submission_status": "AP", "submission_status_date": "20131022", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12049", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/013263Orig1s092ltr.pdf", "date": "20131024", "type": "Letter" }, { "id": "33104", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/013263s092lbl.pdf", "date": "20131025", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "84", "submission_status": "AP", "submission_status_date": "20011025", "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": "19970905", "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": "19840113", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "82", "submission_status": "AP", "submission_status_date": "20010509", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "40689", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/013263_S082_Valium_APPROVAL PACKAGE.pdf", "date": "20061025", "type": "Review" }, { "id": "12048", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/13263s82ltr.pdf", "date": "20010509", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "74", "submission_status": "AP", "submission_status_date": "19891026", "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": "19830120", "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": "20080512", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12047", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf", "date": "20080514", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "100", "submission_status": "AP", "submission_status_date": "20231011", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "75716", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s100lbl.pdf", "date": "20231012", "type": "Label" }, { "id": "75717", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263Orig1s100lbl.pdf#page=19", "date": "20231012", "type": "Medication Guide" }, { "id": "75718", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/013263Orig1s100ltr.pdf", "date": "20231013", "type": "Letter" }, { "id": "75719", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/013263Orig1s100ltr.pdf", "date": "20231013", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "72", "submission_status": "AP", "submission_status_date": "20020207", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "357", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf", "date": "20040629", "type": "Letter" }, { "id": "40687", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S072_VALIUM_AP.pdf", "date": "20070706", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "64", "submission_status": "AP", "submission_status_date": "19821210", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "56", "submission_status": "AP", "submission_status_date": "19820511", "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": "19860827", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "48", "submission_status": "AP", "submission_status_date": "19810109", "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": "19821018", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "54", "submission_status": "AP", "submission_status_date": "19810326", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "46", "submission_status": "AP", "submission_status_date": "19791102", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "60", "submission_status": "AP", "submission_status_date": "19821018", "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": "19750825", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "44", "submission_status": "AP", "submission_status_date": "19800226", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "97", "submission_status": "AP", "submission_status_date": "20230113", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "73164", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/013263Orig1s097ltr.pdf", "date": "20230117", "type": "Letter" }, { "id": "73235", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/013263s097lbl.pdf", "date": "20230117", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "19750124", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "19800617", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "19770921", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "19741213", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "19761027", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "79", "submission_status": "AP", "submission_status_date": "19980904", "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": "20150730", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "85", "submission_status": "AP", "submission_status_date": "20011108", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "77", "submission_status": "AP", "submission_status_date": "19971105", "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": "20130419", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "69", "submission_status": "AP", "submission_status_date": "19850416", "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": "20080512", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "358", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/013263s080,s083ltr.pdf", "date": "20080514", "type": "Letter" }, { "id": "10832", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/013263s083lbl.pdf", "date": "20080605", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "75", "submission_status": "AP", "submission_status_date": "20020207", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "40688", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/013263_S075_VALIUM_AP.pdf", "date": "20070706", "type": "Review" }, { "id": "12046", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16087s79s81ltr.pdf", "date": "20020207", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "67", "submission_status": "AP", "submission_status_date": "19840113", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "81", "submission_status": "AP", "submission_status_date": "20000830", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20044", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/016087_S081_VALIUM_AP.pdf", "date": "20070706", "type": "Review" } ] } ], "application_number": "NDA013263", "sponsor_name": "WAYLIS THERAP", "openfda": { "application_number": [ "NDA013263" ], "brand_name": [ "VALIUM" ], "generic_name": [ "DIAZEPAM" ], "manufacturer_name": [ "Roche Laboratories Inc." ], "product_ndc": [ "0140-0004", "0140-0005" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIAZEPAM" ], "rxcui": [ "104699", "104700", "197590", "197591" ], "spl_id": [ "ea505cdb-6d89-4b8c-8007-ec5a5fe920ce" ], "spl_set_id": [ "554baee5-b171-4452-a50a-41a0946f956c" ], "package_ndc": [ "0140-0004-01", "0140-0005-01", "0140-0005-14" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "Q3JTX2Q7TU" ] }, "products": [ { "product_number": "006", "reference_drug": "Yes", "brand_name": "VALIUM", "active_ingredients": [ { "name": "DIAZEPAM", "strength": "10MG" } ], "reference_standard": "Yes", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "004", "reference_drug": "Yes", "brand_name": "VALIUM", "active_ingredients": [ { "name": "DIAZEPAM", "strength": "5MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "002", "reference_drug": "Yes", "brand_name": "VALIUM", "active_ingredients": [ { "name": "DIAZEPAM", "strength": "2MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" } ] } ] }