{ "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": "10", "submission_status": "AP", "submission_status_date": "20010126", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "20020409", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "24949", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20415s9ltr.pdf", "date": "20020416", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "20000228", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "39", "submission_status": "AP", "submission_status_date": "20250723", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "85987", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/020415Orig1s039ltr.pdf", "date": "20260521", "type": "Letter" }, { "id": "85991", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020415Orig1s039lbl.pdf", "date": "20260521", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "19990511", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "20200304", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "62033", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s029, 021208s019lbl.pdf", "date": "20200304", "type": "Label" }, { "id": "62034", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020415s029, 021208s019ltr.pdf", "date": "20200304", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19970317", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "41354", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-415s003_Remeron.html", "date": "20040908", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "20190905", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "59923", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020415s035lbl.pdf", "date": "20190906", "type": "Label" }, { "id": "59931", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020415Orig1s035, 021208Orig1s025ltr.pdf", "date": "20190906", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19961104", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "27", "submission_status": "AP", "submission_status_date": "20121211", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "20070730", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2526", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020415s019, 021208s010ltr.pdf", "date": "20070802", "type": "Letter" }, { "id": "34639", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020415s019,021208s010lbl.pdf", "date": "20070731", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "20140718", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12571", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf", "date": "20140730", "type": "Label" }, { "id": "24952", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020415Orig1s031,021208Orig1s021ltr.pdf", "date": "20140723", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "20100514", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12567", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf", "date": "20100528", "type": "Label" }, { "id": "24951", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf", "date": "20100521", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "20020930", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2523", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20415slr015ltr.pdf", "date": "20021002", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "20000719", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "20000830", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "38", "submission_status": "AP", "submission_status_date": "20211118", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "69359", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf", "date": "20211119", "type": "Label" }, { "id": "69360", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020415s038,021208s028lbl.pdf#page=23", "date": "20211119", "type": "Medication Guide" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19980409", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "20200429", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "62763", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020415Orig1s034, s036; 021208Orig1s024, s026ltr.pdf", "date": "20200430", "type": "Letter" }, { "id": "62777", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf", "date": "20200430", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "19961107", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "20140930", "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": "20200429", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "62762", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020415Orig1s034, s036; 021208Orig1s024, s026ltr.pdf", "date": "20200430", "type": "Letter" }, { "id": "62776", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020415s034s036,021208s024s026lbl.pdf", "date": "20200430", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "20121030", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12569", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026lbl.pdf", "date": "20121106", "type": "Label" }, { "id": "2528", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020415Orig1s026,021208Orig1s016ltr.pdf", "date": "20121101", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "20050112", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12566", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020415s018,021208s009lbl.pdf", "date": "20050113", "type": "Label" }, { "id": "2525", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020415s018,021208s009ltr.pdf", "date": "20050113", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "20151230", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12572", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020415s032lbl.pdf", "date": "20151231", "type": "Label" }, { "id": "2529", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020415Orig1s032,021208Orig1s022ltr.pdf", "date": "20151231", "type": "Letter" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19960614", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity", "application_docs": [ { "id": "44057", "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm", "date": "20050801", "type": "Other Important Information from FDA" }, { "id": "57465", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020415Orig1s000rev.pdf", "date": "19960614", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "20100514", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12568", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf", "date": "20100528", "type": "Label" }, { "id": "2527", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf", "date": "20100521", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "20040601", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2524", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20415slr016,21208slr008ltr.pdf", "date": "20040607", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "20160708", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12570", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020415s030lbl.pdf", "date": "20160801", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "20111227", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "24950", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020415s022ltr.pdf", "date": "20111229", "type": "Letter" }, { "id": "34640", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020415s022lbl.pdf", "date": "20111227", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "20011120", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" } ], "application_number": "NDA020415", "sponsor_name": "ORGANON", "openfda": { "application_number": [ "NDA020415" ], "brand_name": [ "REMERON" ], "generic_name": [ "MIRTAZAPINE" ], "manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-160", "78206-161", "78206-156", "78206-158", "78206-159" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "MIRTAZAPINE" ], "rxcui": [ "211322", "211323", "283406", "283407", "283485", "311725", "314111", "752869", "752870", "752871" ], "spl_id": [ "8b121c7c-9bcd-4504-b789-3f551a0fe514" ], "spl_set_id": [ "98ad1917-a094-44f5-a28f-a64a8cfcd887" ], "package_ndc": [ "78206-160-01", "78206-161-01", "78206-156-99", "78206-156-01", "78206-158-99", "78206-158-01", "78206-159-99", "78206-159-01" ], "unii": [ "A051Q2099Q" ] }, "products": [ { "product_number": "002", "reference_drug": "Yes", "brand_name": "REMERON", "active_ingredients": [ { "name": "MIRTAZAPINE", "strength": "30MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "003", "reference_drug": "Yes", "brand_name": "REMERON", "active_ingredients": [ { "name": "MIRTAZAPINE", "strength": "45MG **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": "001", "reference_drug": "Yes", "brand_name": "REMERON", "active_ingredients": [ { "name": "MIRTAZAPINE", "strength": "15MG" } ], "reference_standard": "Yes", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" } ] } ] }