{ "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": "2026-08-21", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "19970718", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20319", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S022_ZOCOR_TABLETS.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "75", "submission_status": "AP", "submission_status_date": "20071126", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11690", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s075lbl.pdf", "date": "20071203", "type": "Label" }, { "id": "19175", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s075ltr.pdf", "date": "20071203", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "19950609", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "40993", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s014_ZOCOR_TABLETS.pdf", "date": "20080404", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "67", "submission_status": "AP", "submission_status_date": "20040224", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "41006", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019766_S067&S068_ZOCAR TABS_AP.pdf", "date": "20070706", "type": "Review" }, { "id": "11687", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf", "date": "20040405", "type": "Label" }, { "id": "19172", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf", "date": "20040225", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "81", "submission_status": "AP", "submission_status_date": "20101104", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "33929", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s081lbl.pdf", "date": "20101104", "type": "Label" }, { "id": "1585", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s081ltr.pdf", "date": "20101108", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "19970812", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "19950801", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20317", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s012_ZOCOR_TABLETS.pdf", "date": "20080404", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "65", "submission_status": "AP", "submission_status_date": "20030917", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11685", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf", "date": "20030925", "type": "Label" }, { "id": "19171", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf", "date": "20030929", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "57", "submission_status": "AP", "submission_status_date": "20020506", "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": "19950419", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20316", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_s008_ZOCOR_TABLETS.pdf", "date": "20080404", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "10", "submission_status": "AP", "submission_status_date": "19950216", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "49", "submission_status": "AP", "submission_status_date": "20010604", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "41002", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S049_ZOCOR.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "55", "submission_status": "AP", "submission_status_date": "20020222", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20334", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019766_S055_ZOCOR.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "19950123", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "20010410", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "41000", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S047_ZOCOR.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "103", "submission_status": "AP", "submission_status_date": "20230314", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "73769", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019766Orig1s103ltr.pdf", "date": "20230317", "type": "Letter" }, { "id": "73770", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019766Orig1s103lbl.pdf", "date": "20230315", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "39", "submission_status": "AP", "submission_status_date": "20000822", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19931124", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "53", "submission_status": "AP", "submission_status_date": "20011114", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "41004", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S053_ZOCOR.pdf", "date": "20080219", "type": "Review" }, { "id": "11683", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19766s45s53lbl.pdf", "date": "20030616", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "45", "submission_status": "AP", "submission_status_date": "20011114", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "40999", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S045_ZOCOR.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "98", "submission_status": "AP", "submission_status_date": "20180228", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "52775", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019766s098lbl.pdf", "date": "20180301", "type": "Label" }, { "id": "52778", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019766Orig1s098ltr.pdf", "date": "20180301", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "101", "submission_status": "AP", "submission_status_date": "20200925", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "64697", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019766Orig1s101ltr.pdf", "date": "20200928", "type": "Letter" }, { "id": "64724", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019766s101lbl.pdf", "date": "20200929", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "19930809", "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": "20020506", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19167", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s51ltr.pdf", "date": "20020506", "type": "Letter" }, { "id": "33923", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s51lbl.pdf", "date": "20020506", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "19980629", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20324", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766a_s029.pdf", "date": "19980629", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "20000414", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20330", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_S043_ZOCOR_TABLETS.pdf", "date": "20071119", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "19990915", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20327", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_s035_ZOCOR TABLETS.pdf", "date": "20080404", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "88", "submission_status": "AP", "submission_status_date": "20121031", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11695", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf", "date": "20121102", "type": "Label" }, { "id": "1587", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088ltr.pdf", "date": "20121105", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "27", "submission_status": "AP", "submission_status_date": "19980331", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "19163", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s27ltr.pdf", "date": "19980331", "type": "Letter" }, { "id": "20322", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766s027_Zocor.html", "date": "19980331", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "20000315", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "40998", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_s041_ZOCOR_TABLETS.pdf", "date": "20080804", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "19970317", "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": "19990322", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20326", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_S033_ZOCOR_TABLET.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "86", "submission_status": "AP", "submission_status_date": "20121115", "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": "19971202", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20321", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S025_ZOCOR_TABLETS.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "78", "submission_status": "AP", "submission_status_date": "20100302", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11692", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s078lbl.pdf", "date": "20100302", "type": "Label" }, { "id": "1584", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s078ltr.pdf", "date": "20100308", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "92", "submission_status": "AP", "submission_status_date": "20190301", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "57896", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019766Orig1s092ltr.pdf", "date": "20190305", "type": "Letter" }, { "id": "57905", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019766s092lbl.pdf", "date": "20190304", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "19970523", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "19990423", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20325", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019766_s031_ZOCOR_TABLETS.pdf", "date": "20080404", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "19970909", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20320", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766_S023_ZOCOR_TABLETS.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "76", "submission_status": "AP", "submission_status_date": "20080611", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11691", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019766s076lbl.pdf", "date": "20080619", "type": "Label" }, { "id": "19176", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019766s076ltr.pdf", "date": "20080613", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "90", "submission_status": "AP", "submission_status_date": "20131025", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11696", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019766s090lbl.pdf", "date": "20131031", "type": "Label" }, { "id": "1588", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019766Orig1s090ltr.pdf", "date": "20131028", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "19950801", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "68", "submission_status": "AP", "submission_status_date": "20040224", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11688", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19766slr067,068_zocor_lbl.pdf", "date": "20040405", "type": "Label" }, { "id": "19173", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19766slr067,068ltr.pdf", "date": "20040225", "type": "Letter" }, { "id": "20335", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019766_S067&S068_ZOCAR TABS_AP.pdf", "date": "20070706", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "82", "submission_status": "AP", "submission_status_date": "20110608", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19180", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf", "date": "20110608", "type": "Letter" }, { "id": "33930", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf", "date": "20110608", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "19971031", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "74", "submission_status": "AP", "submission_status_date": "20070601", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "1583", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019766s074ltr.pdf", "date": "20070604", "type": "Letter" }, { "id": "33927", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019766s074lbl.pdf", "date": "20070604", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "19951106", "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": "20030917", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11686", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766slr065,066_simvastatin_lbl.pdf", "date": "20030925", "type": "Label" }, { "id": "1581", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766slr065,066ltr.pdf", "date": "20030929", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "80", "submission_status": "AP", "submission_status_date": "20100408", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11693", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019766s080lbl.pdf", "date": "20100419", "type": "Label" }, { "id": "19179", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019766s080ltr.pdf", "date": "20100413", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "58", "submission_status": "AP", "submission_status_date": "20030416", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "41005", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019766_S058_ZOCOR_TABS_AP.pdf", "date": "20070409", "type": "Review" }, { "id": "11684", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19766se1-058_zocor_lbl.pdf", "date": "20030417", "type": "Label" }, { "id": "19170", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19766se1-058ltr.pdf", "date": "20030529", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "19941221", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "19950630", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "56", "submission_status": "AP", "submission_status_date": "20021018", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "19169", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766se5-056ltr.pdf", "date": "20021018", "type": "Letter" }, { "id": "33925", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766s56lbl.pdf", "date": "20021018", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19940728", "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": "20050517", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19174", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s070ltr.pdf", "date": "20050520", "type": "Letter" }, { "id": "33926", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s070lbl.pdf", "date": "20050520", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "48", "submission_status": "AP", "submission_status_date": "20010410", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "41001", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S048_ZOCOR.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "104", "submission_status": "AP", "submission_status_date": "20230809", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "75027", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019766Orig1s104ltr.pdf", "date": "20230810", "type": "Letter" }, { "id": "75035", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019766s104lbl.pdf", "date": "20230810", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "19940222", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "54", "submission_status": "AP", "submission_status_date": "20020321", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20333", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019766_S054_ZOCOR.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "99", "submission_status": "AP", "submission_status_date": "20220307", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "70436", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019766Orig1s099ltr.pdf", "date": "20220308", "type": "Letter" }, { "id": "70488", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019766s099lbl.pdf", "date": "20220311", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "102", "submission_status": "AP", "submission_status_date": "20220531", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "71186", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019766Orig1s102ltr.pdf", "date": "20220601", "type": "Letter" }, { "id": "71199", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019766s102lbl.pdf", "date": "20220601", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19940222", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "52", "submission_status": "AP", "submission_status_date": "20020321", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "19168", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19766s52ltr.pdf", "date": "20020321", "type": "Letter" }, { "id": "20332", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-766s052_Zocor.html", "date": "20020321", "type": "Review" }, { "id": "33924", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19766S52lbl.pdf", "date": "20020321", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "44", "submission_status": "AP", "submission_status_date": "20001211", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20331", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019766_S044_ZOCOR_TABLET.pdf", "date": "20071119", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19921127", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "100", "submission_status": "AP", "submission_status_date": "20191004", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "60420", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019766Orig1s100ltr.pdf", "date": "20191009", "type": "Letter" }, { "id": "60570", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019766s100lbl.pdf", "date": "20191015", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "19991122", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "20328", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19766s34_Zocor.pdf", "date": "19991122", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "20010913", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "41003", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019766_S050_ZOCOR.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19911223", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity", "application_docs": [ { "id": "44036", "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm", "date": "20080125", "type": "Other Important Information from FDA" }, { "id": "44446", "title": "Patent Request", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_Zocor_Patent_Request.pdf", "date": "20070709", "type": "Other" } ] }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "19980710", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "19164", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf", "date": "19980710", "type": "Letter" }, { "id": "20323", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/119766-s28.html", "date": "19980710", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "20001107", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "95", "submission_status": "AP", "submission_status_date": "20160301", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "19991122", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "40997", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19766s34_Zocor.pdf", "date": "19991122", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "87", "submission_status": "AP", "submission_status_date": "20121031", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19182", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766Orig1s087,s088ltr.pdf", "date": "20121105", "type": "Letter" }, { "id": "33932", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s087s088lbl.pdf", "date": "20121102", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "19980710", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "40995", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/119766-s28.html", "date": "19980710", "type": "Review" }, { "id": "19162", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19766s026s028.pdf", "date": "19980710", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "20000427", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "19166", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19766S40LTR.PDF", "date": "20000427", "type": "Letter" }, { "id": "20329", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor.html", "date": "20000427", "type": "Review" }, { "id": "33922", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19766-S040_Zocor_prntlbl.pdf", "date": "20000427", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "79", "submission_status": "AP", "submission_status_date": "20110610", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19178", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf", "date": "20110617", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "93", "submission_status": "AP", "submission_status_date": "20150202", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11698", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019766s093lbl.pdf", "date": "20150203", "type": "Label" }, { "id": "1590", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019766Orig1s093ltr.pdf", "date": "20150203", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "19970519", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "40994", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019766a_s018.pdf", "date": "19970519", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "19990805", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "19165", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19766s32ltr.pdf", "date": "19990805", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "85", "submission_status": "AP", "submission_status_date": "20120228", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11694", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019766s085lbl.pdf", "date": "20120301", "type": "Label" }, { "id": "19181", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019766s085ltr.pdf", "date": "20120229", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "77", "submission_status": "AP", "submission_status_date": "20110608", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "41007", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766s077.pdf", "date": "20110815", "type": "Review" }, { "id": "19177", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s077,s082ltr.pdf", "date": "20110608", "type": "Letter" }, { "id": "33928", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s077s082lbl.pdf", "date": "20110608", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "91", "submission_status": "AP", "submission_status_date": "20140227", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11697", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019766s091lbl.pdf", "date": "20140304", "type": "Label" }, { "id": "1589", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019766Orig1s091ltr.pdf", "date": "20140228", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "19961122", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "20318", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019766_S016_ZOCOR_TABLETS.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "19980924", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "40996", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019766_S030_ZOCOR_TABLETS.pdf", "date": "20080219", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "69", "submission_status": "AP", "submission_status_date": "20050831", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11689", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019766s069lbl.pdf", "date": "20050908", "type": "Label" }, { "id": "1582", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019766s069ltr.pdf", "date": "20050908", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "83", "submission_status": "AP", "submission_status_date": "20111006", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "41008", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/019766Orig1s083.pdf", "date": "20120606", "type": "Review" }, { "id": "1586", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019766s083ltr.pdf", "date": "20111012", "type": "Letter" }, { "id": "33931", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019766s083lbl.pdf", "date": "20111012", "type": "Label" } ] } ], "application_number": "NDA019766", "sponsor_name": "ORGANON", "openfda": { "application_number": [ "NDA019766" ], "brand_name": [ "ZOCOR" ], "generic_name": [ "SIMVASTATIN" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-180", "78206-182", "78206-181" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SIMVASTATIN" ], "rxcui": [ "104490", "104491", "152923", "198211", "312961", "314231" ], "spl_id": [ "11256523-425c-48e8-afe1-e3a4e28c892e" ], "spl_set_id": [ "8f55d5de-5a4f-4a39-8c84-c53976dd6af9" ], "package_ndc": [ "78206-182-01", "78206-182-02", "78206-181-02", "78206-181-01", "78206-180-01", "78206-180-02" ], "nui": [ "N0000175589", "N0000000121" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ], "unii": [ "AGG2FN16EV" ] }, "products": [ { "product_number": "005", "reference_drug": "Yes", "brand_name": "ZOCOR", "active_ingredients": [ { "name": "SIMVASTATIN", "strength": "80MG **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": "003", "reference_drug": "Yes", "brand_name": "ZOCOR", "active_ingredients": [ { "name": "SIMVASTATIN", "strength": "20MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "ZOCOR", "active_ingredients": [ { "name": "SIMVASTATIN", "strength": "5MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "004", "reference_drug": "Yes", "brand_name": "ZOCOR", "active_ingredients": [ { "name": "SIMVASTATIN", "strength": "40MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "002", "reference_drug": "Yes", "brand_name": "ZOCOR", "active_ingredients": [ { "name": "SIMVASTATIN", "strength": "10MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" } ] } ] }