{ "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": "26", "submission_status": "AP", "submission_status_date": "20031219", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "41731", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S026_SINGULAIR_TABLETS_AP.pdf", "date": "20070706", "type": "Review" }, { "id": "25943", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr026,20830slr029,21409slr007ltr.pdf", "date": "20031223", "type": "Letter" }, { "id": "35435", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr026,20830slr029,21409slr007_singulair_lbl.pdf", "date": "20031229", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "20020711", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "20041229", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "35437", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s032,20830s034,21409s011lbl.pdf", "date": "20050111", "type": "Label" }, { "id": "3443", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s032,20830s034,21409s011ltr.pdf", "date": "20050111", "type": "Letter" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19980220", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity", "application_docs": [ { "id": "41728", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020829s000_SingulairTOC.html", "date": "19980220", "type": "Review" }, { "id": "53344", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021409 montelukast clinical prea.pdf", "date": "19000101", "type": "Pediatric Medical Review" }, { "id": "53345", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021409 montelukast clinpharm prea.pdf", "date": "19000101", "type": "Pediatric Clinical Pharmacology Review" }, { "id": "53346", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/021409 montelukast statistical prea.pdf", "date": "19000101", "type": "Pediatric Statistical Review" }, { "id": "25939", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20829ltr.pdf", "date": "19980220", "type": "Letter" }, { "id": "35432", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20829lbl.pdf", "date": "19980220", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "20020211", "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": "20161213", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "46161", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020829Orig1s069,020830Orig1s071,021409Orig1s047ltr.pdf", "date": "20161215", "type": "Letter" }, { "id": "46176", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020829s069,020830s071,021409s047lbl.pdf", "date": "20161214", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "20011026", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "67", "submission_status": "AP", "submission_status_date": "20140128", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "59", "submission_status": "AP", "submission_status_date": "20120326", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "25953", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829s059,020830s061,021409s036ltr.pdf", "date": "20120328", "type": "Letter" }, { "id": "35442", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s059lbl.pdf", "date": "20120326", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "73", "submission_status": "AP", "submission_status_date": "20200429", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "62751", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020829Orig1s073, 020830Orig1s075, 021409Orig1s051ltr.pdf", "date": "20200430", "type": "Letter" }, { "id": "62754", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/20829Orig1s073,20830Orig1s075,21409Orig1s075lbl.pdf", "date": "20201204", "type": "Label" }, { "id": "68745", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/020829Orig1s073.pdf", "date": "20210924", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "20010802", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13505", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20829s12lbl.pdf", "date": "20030424", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "65", "submission_status": "AP", "submission_status_date": "20130321", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13522", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020829s065,020830s066,021409s042lbl.pdf", "date": "20130326", "type": "Label" }, { "id": "25956", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s065,020830Orig1s066,021409Orig1s042ltr.pdf", "date": "20130322", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "57", "submission_status": "AP", "submission_status_date": "20110427", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3454", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s057,020830s059,021409s034ltr.pdf", "date": "20110503", "type": "Letter" }, { "id": "13517", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s057,020830s059,021409s034lbl.pdf", "date": "20110429", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "71", "submission_status": "AP", "submission_status_date": "20181221", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "57022", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020829s070s071,020830s072s073,021409s048s049lbl.pdf", "date": "20181226", "type": "Label" }, { "id": "57069", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020829Orig1s070s071,020830Orig1s072s073,021409Orig1s048s049Ltr.pdf", "date": "20181230", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "10", "submission_status": "AP", "submission_status_date": "20000905", "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": "20090127", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13514", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s049,020830s051,021409s027lbl.pdf", "date": "20090204", "type": "Label" }, { "id": "25950", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s049,020830s051,021409s027ltr.pdf", "date": "20090130", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "63", "submission_status": "AP", "submission_status_date": "20120927", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13521", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829S63-20830S64-21409S40lbl.pdf", "date": "20120928", "type": "Label" }, { "id": "25955", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s063,020830Orig1s064,021409Orig1s040ltr.pdf", "date": "20121002", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "20001017", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "55", "submission_status": "AP", "submission_status_date": "20100810", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "86181", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/20829Orig1s055.pdf", "date": "20260608", "type": "Review" }, { "id": "3453", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s055,020830s056,021409s031ltr.pdf", "date": "20100816", "type": "Letter" }, { "id": "35441", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s055,020830s056,021409s031lbl.pdf", "date": "20100819", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "20080421", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13512", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s047,020830s049,021409s025lbl.pdf", "date": "20080605", "type": "Label" }, { "id": "3451", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s047, 020830s049, 021409s025ltr.pdf", "date": "20080422", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "61", "submission_status": "AP", "submission_status_date": "20121018", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13519", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s061,020830s063,021409s039lbl.pdf", "date": "20121022", "type": "Label" }, { "id": "3456", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s061,020830Orig1s063,021409Orig1s039ltr.pdf", "date": "20121022", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19990728", "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": "20061208", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13510", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s039,020830s041,021409s019lbl.pdf", "date": "20061214", "type": "Label" }, { "id": "3448", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s039, 020830s041, 021409s019ltr.pdf", "date": "20061228", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "19990121", "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": "20050627", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3446", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s037,020830s039,021409s017Rev2.pdf", "date": "20050629", "type": "Letter" }, { "id": "35439", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s037,020830s039,021409s017lbl.pdf", "date": "20050629", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "51", "submission_status": "AP", "submission_status_date": "20090819", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3452", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020829s051,020830s052,021409s028ltr.pdf", "date": "20091110", "type": "Letter" }, { "id": "13515", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020829s051_020830s052_021409s028lbl.pdf", "date": "20090915", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "20041115", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19980430", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "20070413", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3449", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf", "date": "20070420", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "20050526", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13509", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s035,020830s037,021409s015lbl.pdf", "date": "20050527", "type": "Label" }, { "id": "25946", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s035,020830s037,021409s015ltr.pdf", "date": "20050527", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19990212", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "41729", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20830-s001_singulair.pdf", "date": "20010705", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "20070413", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25947", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf", "date": "20070420", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "20021007", "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": "20050727", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "3444", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s033,020830s035,021409s012ltr.pdf", "date": "20050729", "type": "Letter" }, { "id": "41732", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020829s033_020830s035_021409s012Approv.pdf", "date": "20120214", "type": "Review" }, { "id": "13507", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s033,020830s035,021409s012lbl.pdf", "date": "20050729", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "20031105", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20987", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S025_SINGULAIR_TABLETS_AP.pdf", "date": "20070706", "type": "Review" }, { "id": "25942", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr025,20830slr028ltr.pdf", "date": "20031113", "type": "Letter" }, { "id": "35434", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr025,20830slr028_singulair_lbl.pdf", "date": "20031113", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "20021231", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "13506", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20829se1-017_singulair_lbl.pdf", "date": "20030407", "type": "Label" }, { "id": "25940", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829se1-017,20830se1-020ltr.pdf", "date": "20021231", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "20041115", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25944", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20829s031,20830s033,21409s010ltr.pdf", "date": "20041117", "type": "Letter" }, { "id": "35436", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20829s031,20830s033,21409s010lbl.pdf", "date": "20041117", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "20031002", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "41730", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020829_S023 & 020830_S026 & 021409_S005_SINGULAR_AP.pdf", "date": "20070709", "type": "Review" }, { "id": "25941", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20829slr023,20830slr026,21409slr005ltr.pdf", "date": "20031009", "type": "Letter" }, { "id": "35433", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20829slr023,20830slr026,21409slr005_singulair_lbl.pdf", "date": "20031010", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "68", "submission_status": "AP", "submission_status_date": "20141126", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25958", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045ltr.pdf", "date": "20141128", "type": "Letter" }, { "id": "35443", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020829Orig1s068,020830Orig1s070,021409Orig1s045lbl.pdf", "date": "20141219", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "74", "submission_status": "AP", "submission_status_date": "20210222", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "66334", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020829Orig1s074, 020830Orig1s076, 021409Orig1s052ltr.pdf", "date": "20210223", "type": "Letter" }, { "id": "66347", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s076,021409s052lbl.pdf", "date": "20210224", "type": "Label" }, { "id": "66348", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020829s074,020830s076,021409s052lbl.pdf#page=25", "date": "20210224", "type": "Medication Guide" } ] }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "20010618", "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": "20131230", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13523", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021409s043lbl.pdf", "date": "20131231", "type": "Label" }, { "id": "25957", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020829Orig1s066,020830Orig1s068,021409Orig1s043ltr.pdf", "date": "20131231", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "72", "submission_status": "AP", "submission_status_date": "20190809", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "59671", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020829Orig1s072, 020830Orig1s074, 021409Orig1s050ltr.pdf", "date": "20190812", "type": "Letter" }, { "id": "59674", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020829s072,020830s074,021409s050lbl.pdf", "date": "20190812", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "70", "submission_status": "AP", "submission_status_date": "20181221", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "57023", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020829s070s071,020830s072s073,021409s048s049lbl.pdf", "date": "20181226", "type": "Label" }, { "id": "57078", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020829Orig1s070s071,020830Orig1s072s073,021409Orig1s048s049Ltr.pdf", "date": "20181231", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "48", "submission_status": "AP", "submission_status_date": "20080424", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13513", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s048lbl.pdf", "date": "20080429", "type": "Label" }, { "id": "25949", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s048, 020830s050, 021409s026Ltr.pdf", "date": "20080428", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "62", "submission_status": "AP", "submission_status_date": "20120716", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13520", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020829s062lbl.pdf", "date": "20120718", "type": "Label" }, { "id": "25954", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020829Orig1s062ltr.pdf", "date": "20120717", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "54", "submission_status": "AP", "submission_status_date": "20110610", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25952", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf", "date": "20110617", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "46", "submission_status": "AP", "submission_status_date": "20080307", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3450", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020829s046, 020830s048, 021409s023ltr.pdf", "date": "20080311", "type": "Letter" }, { "id": "86180", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/20829Orig1s046.pdf", "date": "20260608", "type": "Review" }, { "id": "13511", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020829s046lbl.pdf", "date": "20080311", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "19981201", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "60", "submission_status": "AP", "submission_status_date": "20111216", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3455", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020829s060,020830s062,21409s037ltr.pdf", "date": "20111221", "type": "Letter" }, { "id": "13518", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020829s060,020830s062,021409s037lbl.pdf", "date": "20111220", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "38", "submission_status": "AP", "submission_status_date": "20060519", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "35440", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020829s38,020830s40,021409s018lbl.pdf", "date": "20060522", "type": "Label" }, { "id": "3447", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020829s038, 020830s040, 021409s018LTR.pdf", "date": "20060522", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "52", "submission_status": "AP", "submission_status_date": "20100426", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13516", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s052lbl.pdf", "date": "20100428", "type": "Label" }, { "id": "25951", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020829s052,020830s053,021409s029ltr.pdf", "date": "20100429", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19980918", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "20070413", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "35438", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020829s036,020830s038,021409s016lbl.pdf", "date": "20070420", "type": "Label" }, { "id": "3445", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s036, 020830s038, 021409s016ltr.pdf", "date": "20070420", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "19980402", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "20070413", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25948", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020829s041,020829s042,020829s043,020830s043ltr.pdf", "date": "20070420", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "20051130", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "13508", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020829s034,020830s036,021409s014lbl.pdf", "date": "20051205", "type": "Label" }, { "id": "25945", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020829s034,020830s036,021409s014ltr.pdf", "date": "20051206", "type": "Letter" } ] } ], "application_number": "NDA020829", "sponsor_name": "ORGANON", "openfda": { "application_number": [ "NDA020829" ], "brand_name": [ "SINGULAIR" ], "generic_name": [ "MONTELUKAST SODIUM" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-172", "78206-171", "78206-170", "78206-173" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "MONTELUKAST SODIUM" ], "rxcui": [ "153892", "153893", "200224", "242438", "261367", "311759", "351246", "404406" ], "spl_id": [ "57a12189-3bb3-4a5d-b5fe-fc57db87c134" ], "spl_set_id": [ "482dcc92-b47f-4ea6-854a-f5ac2aea7842" ], "package_ndc": [ "78206-171-01", "78206-170-01", "78206-173-01", "78206-172-01", "78206-172-02" ], "unii": [ "U1O3J18SFL" ] }, "products": [ { "product_number": "002", "reference_drug": "Yes", "brand_name": "SINGULAIR", "active_ingredients": [ { "name": "MONTELUKAST SODIUM", "strength": "EQ 10MG BASE" } ], "reference_standard": "Yes", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" } ] } ] }