{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-05-19", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "19930610", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19790917", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "19931006", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "19860825", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "19820218", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "19920121", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "19910802", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "19891107", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "19850627", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "19881107", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "58", "submission_status": "AP", "submission_status_date": "20070713", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "778", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf", "date": "20070724", "type": "Letter" }, { "id": "33392", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018013s58lbl.pdf", "date": "20070716", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "64", "submission_status": "AP", "submission_status_date": "20190409", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "58269", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018013s064lbl.pdf", "date": "20190410", "type": "Label" }, { "id": "58270", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018013s064lbl.pdf#page=15", "date": "20190410", "type": "Medication Guide" }, { "id": "58276", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018013Orig1s064ltr.pdf", "date": "20190410", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "56", "submission_status": "AP", "submission_status_date": "20050112", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11113", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf", "date": "20050113", "type": "Label" }, { "id": "13977", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18012s026,18013s056ltr.pdf", "date": "20050113", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "48", "submission_status": "AP", "submission_status_date": "19951207", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "62", "submission_status": "AP", "submission_status_date": "20140710", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11114", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s062lbl.pdf", "date": "20140711", "type": "Label" }, { "id": "13979", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf", "date": "20140711", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "54", "submission_status": "AP", "submission_status_date": "20010607", "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": "19820325", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "38", "submission_status": "AP", "submission_status_date": "19930817", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "52", "submission_status": "AP", "submission_status_date": "20000427", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19810724", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "44", "submission_status": "AP", "submission_status_date": "19940707", "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": "19930616", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "19791120", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "19990428", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "19940401", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19790614", "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": "19930723", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "19900326", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19780629", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "19920312", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "19850611", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "19930826", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "19841211", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19770801", "review_priority": "STANDARD", "submission_class_code": "TYPE 5", "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer", "application_docs": [ { "id": "23539", "url": "http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273", "date": "20070509", "type": "Other Important Information from FDA" } ] }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "19900116", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "19840501", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "10", "submission_status": "AP", "submission_status_date": "19820602", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "63", "submission_status": "AP", "submission_status_date": "20140728", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "779", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf", "date": "20140729", "type": "Letter" }, { "id": "11115", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s063lbl.pdf", "date": "20140729", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "55", "submission_status": "AP", "submission_status_date": "20041206", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "19950918", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "61", "submission_status": "AP", "submission_status_date": "20121026", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13978", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf", "date": "20121029", "type": "Letter" }, { "id": "33393", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf", "date": "20121026", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "39", "submission_status": "AP", "submission_status_date": "19930723", "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": "20010731", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20101", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018013_s053_PAMELOR CAPSULES.pdf", "date": "20090914", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "19810626", "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": "19930616", "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": "19990415", "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": "19910313", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "19940415", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" } ], "application_number": "NDA018013", "sponsor_name": "SPECGX LLC", "openfda": { "application_number": [ "NDA018013" ], "brand_name": [ "PAMELOR" ], "generic_name": [ "NORTRIPTYLINE HYDROCHLORIDE" ], "manufacturer_name": [ "SpecGx LLC" ], "product_ndc": [ "0406-9910", "0406-9911", "0406-9912", "0406-9913" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "NORTRIPTYLINE HYDROCHLORIDE" ], "rxcui": [ "198045", "198046", "198047", "209329", "209339", "209350", "209391", "317136" ], "spl_id": [ "0c3b20b3-e852-4959-815a-90ed989a30e1" ], "spl_set_id": [ "e17dc299-f52d-414d-ab6e-e809bd6f8acb" ], "package_ndc": [ "0406-9910-03", "0406-9911-03", "0406-9912-03", "0406-9913-03" ], "unii": [ "00FN6IH15D" ] }, "products": [ { "product_number": "003", "reference_drug": "Yes", "brand_name": "PAMELOR", "active_ingredients": [ { "name": "NORTRIPTYLINE HYDROCHLORIDE", "strength": "EQ 75MG BASE" } ], "reference_standard": "No", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Discontinued", "te_code": "AB" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "PAMELOR", "active_ingredients": [ { "name": "NORTRIPTYLINE HYDROCHLORIDE", "strength": "EQ 10MG BASE" } ], "reference_standard": "No", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Discontinued", "te_code": "AB" }, { "product_number": "004", "reference_drug": "Yes", "brand_name": "PAMELOR", "active_ingredients": [ { "name": "NORTRIPTYLINE HYDROCHLORIDE", "strength": "EQ 50MG BASE" } ], "reference_standard": "No", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Discontinued", "te_code": "AB" }, { "product_number": "002", "reference_drug": "Yes", "brand_name": "PAMELOR", "active_ingredients": [ { "name": "NORTRIPTYLINE HYDROCHLORIDE", "strength": "EQ 25MG BASE" } ], "reference_standard": "No", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Discontinued", "te_code": "AB" } ] } ] }