{ "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": "3", "submission_status": "AP", "submission_status_date": "19961001", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "20051006", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "41530", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020659_S034_NORVIR.pdf", "date": "20071119", "type": "Review" }, { "id": "52166", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20659s034_ritonavir_Norvir-MedRev.pdf", "date": "19000101", "type": "Pediatric Medical Review" }, { "id": "52167", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/20659s034_ritonavir_Norvir-ClinPharmRev.pdf", "date": "19000101", "type": "Pediatric Clinical Pharmacology Review" }, { "id": "52168", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020659, 020680_ritonavir_4-16-99_HFD530_orig.pdf", "date": "19000101", "type": "Pediatric Written Request" }, { "id": "52169", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020659, 020680_ritonavir_WR_amend1.pdf", "date": "19000101", "type": "Pediatric Amendment 1" }, { "id": "12939", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020659s034,020945s017lbl.pdf", "date": "20051010", "type": "Label" }, { "id": "25457", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020659s034,020945s017ltr.pdf", "date": "20051011", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "20010306", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3017", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20659s26ltr.pdf", "date": "20010306", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "20070731", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "35096", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s040,020945s020lbl.pdf", "date": "20070802", "type": "Label" }, { "id": "25458", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s040, 020945s020ltr.pdf", "date": "20070802", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19961001", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "19990412", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "20050328", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3020", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20659s032,20945s014ltr.pdf", "date": "20050330", "type": "Letter" }, { "id": "35093", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20659s032,20945s014lbl.pdf", "date": "20050330", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "20000901", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "19981030", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "20030910", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12938", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20659slr030,20945slr013_norvir_lbl.pdf", "date": "20030925", "type": "Label" }, { "id": "3019", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20659slr030,20945slr013ltr.pdf", "date": "20030925", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "69", "submission_status": "AP", "submission_status_date": "20181115", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "56545", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020659s069lbl.pdf", "date": "20181123", "type": "Label" }, { "id": "56681", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020659Orig1s069,022417Orig1s021,0209512Orig1s004ltr.pdf", "date": "20181207", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "19991026", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "19980724", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "67", "submission_status": "AP", "submission_status_date": "20170607", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "48676", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022417s19_020659s67lbl.pdf", "date": "20170608", "type": "Label" }, { "id": "48677", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020659Orig1s067,022417Orig1s019ltr.pdf", "date": "20170608", "type": "Letter" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19960301", "review_priority": "PRIORITY", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity", "application_docs": [ { "id": "57468", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020659Orig1s000rev.pdf", "date": "19970409", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "19991028", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "73", "submission_status": "AP", "submission_status_date": "20221215", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "72917", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022417Orig1s025;020659Orig1s073;209512Orig1s008ltr.pdf", "date": "20221216", "type": "Letter" }, { "id": "72959", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022417Orig1s025,020659Orig1s073,209512Orig1s008lbl.pdf", "date": "20221220", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "19980212", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "65", "submission_status": "AP", "submission_status_date": "20160915", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "45288", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022417s017,020659Orig1s065ltr.pdf", "date": "20160919", "type": "Letter" }, { "id": "45311", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s065,022417s017lbl.pdf", "date": "20160915", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "57", "submission_status": "AP", "submission_status_date": "20121120", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3026", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022417Orig1s008,020659Orig1s057ltr.pdf", "date": "20121123", "type": "Letter" }, { "id": "35100", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022417s008,020659s057lbl.pdf", "date": "20121128", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "71", "submission_status": "AP", "submission_status_date": "20191219", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "61378", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020659Orig1s071, 209512Orig1s006, 022417Orig1s023ltr.pdf", "date": "20191223", "type": "Letter" }, { "id": "61483", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s071, 209512s006, 022417s023lbl.pdf", "date": "20191231", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "10", "submission_status": "AP", "submission_status_date": "19980123", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "63", "submission_status": "AP", "submission_status_date": "20161122", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "45948", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020659Orig1s063,022417Orig1s015ltr.pdf", "date": "20161123", "type": "Letter" }, { "id": "45989", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659S063_022417S15lbl.pdf", "date": "20161201", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "55", "submission_status": "AP", "submission_status_date": "20111206", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12943", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.pdf", "date": "20111214", "type": "Label" }, { "id": "3024", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020659s055,022417s006ltr.pdf", "date": "20111208", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "20091123", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25462", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020945s026,020659s047ltr.pdf", "date": "20100120", "type": "Letter" }, { "id": "35098", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020945s026,020659s047lbl.pdf", "date": "20091202", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "61", "submission_status": "AP", "submission_status_date": "20150327", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3028", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s013,020659Orig1s061ltr.pdf", "date": "20150403", "type": "Letter" }, { "id": "35101", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022417s013,020659s061lbl.pdf", "date": "20150407", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "39", "submission_status": "AP", "submission_status_date": "20080516", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3023", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s039ltr.pdf", "date": "20080520", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "19970314", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "45", "submission_status": "AP", "submission_status_date": "20100210", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12941", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s045lbl.pdf", "date": "20100216", "type": "Label" }, { "id": "25461", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020659s045ltr.pdf", "date": "20100217", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "19970917", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "20081001", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25460", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s043, 020945s023ltr.pdf", "date": "20081002", "type": "Letter" }, { "id": "35097", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020659s043,020945s023lbl.pdf", "date": "20090804", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19960924", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "27", "submission_status": "AP", "submission_status_date": "20020314", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "35092", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20659S27lbl.pdf", "date": "20020314", "type": "Label" }, { "id": "3018", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20659s27ltr.pdf", "date": "20020314", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "19990409", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "20051109", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "41529", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020659_S033_NORVIR.pdf", "date": "20071119", "type": "Review" }, { "id": "3021", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020945s016,020659s033ltr.pdf", "date": "20051118", "type": "Letter" }, { "id": "35094", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020945s016,020659s033lbl.pdf", "date": "20051117", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "20010821", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12937", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf", "date": "20030425", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "19990226", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "20000508", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "19980925", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "68", "submission_status": "AP", "submission_status_date": "20170929", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "49917", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf", "date": "20171003", "type": "Label" }, { "id": "49924", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209512Orig1s002,022417Origs020,020659Orig1s068ltr.pdf", "date": "20171003", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "19991021", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "19990526", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "41528", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020659s013_020680s011_Norvir.html", "date": "20050427", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "66", "submission_status": "AP", "submission_status_date": "20170629", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "48876", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf", "date": "20170630", "type": "Label" }, { "id": "48884", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020659Orig1s066,022417Orig1s018,209512Orig1s001ltr.pdf", "date": "20170630", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "58", "submission_status": "AP", "submission_status_date": "20131107", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12944", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020659s058_022417s010lbl.pdf", "date": "20131108", "type": "Label" }, { "id": "25464", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020659Orig1s058,022417Orig1s010ltr.pdf", "date": "20131108", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "72", "submission_status": "AP", "submission_status_date": "20201021", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "64973", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020659Orig1s072, 022417Orig1s024, 209512Orig1s007ltr.pdf", "date": "20201022", "type": "Letter" }, { "id": "65022", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020659s072,022417s024,209512s007lbl.pdf", "date": "20201023", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "19980501", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "64", "submission_status": "AP", "submission_status_date": "20161222", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "46511", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s064,022417s016lbl.pdf", "date": "20161222", "type": "Label" }, { "id": "46530", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020659Orig1s064022417Orig1s016ltr.pdf", "date": "20161223", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "56", "submission_status": "AP", "submission_status_date": "20120217", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "35099", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020659s056,022417s007lbl.pdf", "date": "20120222", "type": "Label" }, { "id": "3025", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020659s056,022417s007ltr.pdf", "date": "20120227", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "70", "submission_status": "AP", "submission_status_date": "20190821", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "59804", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020659Orig1s070, 209512Orig1s005, 022417Orig1s022ltr.pdf", "date": "20190822", "type": "Letter" }, { "id": "59814", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s070,022417s022,209512s005lbl.pdf", "date": "20190822", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "62", "submission_status": "AP", "submission_status_date": "20151110", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25465", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020659Orig1s062,022417Orig1s14ltr.pdf", "date": "20151117", "type": "Letter" }, { "id": "35102", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s062,022417s014lbl.pdf", "date": "20151112", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "19971031", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "60", "submission_status": "AP", "submission_status_date": "20150316", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12945", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.pdf", "date": "20150319", "type": "Label" }, { "id": "3027", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s012,020659Orig1s060ltr.pdf", "date": "20150317", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19970509", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "20070510", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "35095", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s036,020945s018lbl.pdf", "date": "20070516", "type": "Label" }, { "id": "3022", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s036,020945s018ltr.pdf", "date": "20070516", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "19970108", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "20100427", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12942", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s050,022417s001lbl.pdf", "date": "20100507", "type": "Label" }, { "id": "25463", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020659s050,022417s001ltr.pdf", "date": "20100503", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "20021224", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "20080829", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12940", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020945s022,020659s042lbl.pdf", "date": "20080829", "type": "Label" }, { "id": "25459", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020945s022, 020659s042ltr.pdf", "date": "20080903", "type": "Letter" } ] } ], "application_number": "NDA020659", "sponsor_name": "ABBVIE", "products": [ { "product_number": "001", "reference_drug": "Yes", "brand_name": "NORVIR", "active_ingredients": [ { "name": "RITONAVIR", "strength": "80MG/ML" } ], "reference_standard": "No", "dosage_form": "SOLUTION", "route": "ORAL", "marketing_status": "Discontinued" } ] } ] }