{ "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": "29", "submission_status": "AP", "submission_status_date": "19800214", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "19860624", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "19820201", "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": "19770301", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "19750404", "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": "19820211", "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": "19800728", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "19751006", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19641120", "review_priority": "STANDARD", "submission_class_code": "TYPE 2", "submission_class_code_description": "Type 2 - New Active Ingredient", "application_docs": [ { "id": "44003", "url": "http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273", "date": "20070509", "type": "Other Important Information from FDA" } ] }, { "submission_type": "SUPPL", "submission_number": "68", "submission_status": "AP", "submission_status_date": "20140807", "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": "19750415", "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": "20121119", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12065", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf", "date": "20121121", "type": "Letter" }, { "id": "33120", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf", "date": "20121126", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "58", "submission_status": "AP", "submission_status_date": "20000523", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "72", "submission_status": "AP", "submission_status_date": "20250624", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "82661", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/014399Orig1s072ltr.pdf", "date": "20250625", "type": "Letter" }, { "id": "82715", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/014399s072lbl.pdf", "date": "20250630", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "64", "submission_status": "AP", "submission_status_date": "20070730", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12063", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/014399s064ltr.pdf", "date": "20070731", "type": "Letter" }, { "id": "33119", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/014399s064lbl.pdf", "date": "20070731", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "56", "submission_status": "AP", "submission_status_date": "19920903", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "48", "submission_status": "AP", "submission_status_date": "19890321", "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": "20050112", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "374", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/14399s062ltr.pdf", "date": "20050113", "type": "Letter" }, { "id": "33118", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/14399s062lBL.pdf", "date": "20050113", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "46", "submission_status": "AP", "submission_status_date": "19880620", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "60", "submission_status": "AP", "submission_status_date": "20000523", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "38", "submission_status": "AP", "submission_status_date": "19820622", "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": "19911211", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "44", "submission_status": "AP", "submission_status_date": "19870403", "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": "19820201", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "19900425", "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": "19901210", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "19820201", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "19850429", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "19740702", "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": "19820201", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "19800818", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "69", "submission_status": "AP", "submission_status_date": "20140702", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "377", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/014399Orig1s069ltr.pdf", "date": "20140703", "type": "Letter" }, { "id": "10843", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/014399s069lbl.pdf", "date": "20140703", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "19760528", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "67", "submission_status": "AP", "submission_status_date": "20121119", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "376", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/014399Orig1s066,s067ltr.pdf", "date": "20121121", "type": "Letter" }, { "id": "23096", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067mg.pdf", "date": "20121126", "type": "Medication Guide" }, { "id": "33121", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/014399s066s067lbl.pdf", "date": "20121126", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "19760625", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "65", "submission_status": "AP", "submission_status_date": "20091026", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "10842", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/014399s065lbl.pdf", "date": "20091030", "type": "Label" }, { "id": "12064", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/014399s065ltr.pdf", "date": "20091119", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "71", "submission_status": "AP", "submission_status_date": "20181109", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "56418", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/014399s071lbl.pdf", "date": "20181113", "type": "Label" }, { "id": "56444", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/014399Orig1s071ltr.pdf", "date": "20181115", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "49", "submission_status": "AP", "submission_status_date": "19901210", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "63", "submission_status": "AP", "submission_status_date": "20060411", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "10841", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/014399s063lbl.pdf", "date": "20060412", "type": "Label" }, { "id": "375", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/014399s063ltr.pdf", "date": "20060413", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "55", "submission_status": "AP", "submission_status_date": "20000523", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "19880330", "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": "20000523", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "53", "submission_status": "AP", "submission_status_date": "19911211", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "45", "submission_status": "AP", "submission_status_date": "19881115", "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": "19820622", "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": "19890619", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" } ], "application_number": "NDA014399", "sponsor_name": "VALIDUS PHARMS", "openfda": { "application_number": [ "NDA014399" ], "brand_name": [ "NORPRAMIN" ], "generic_name": [ "DESIPRAMINE HYDROCHLORIDE" ], "manufacturer_name": [ "Validus Pharmaceuticals LLC" ], "product_ndc": [ "30698-007", "30698-011", "30698-015", "30698-019", "30698-020", "30698-021" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DESIPRAMINE HYDROCHLORIDE" ], "rxcui": [ "1099288", "1099290", "1099292", "1099294", "1099296", "1099298", "1099300", "1099302", "1099304", "1099306", "1099316", "1099318" ], "spl_id": [ "3904bc92-b199-2543-e063-6294a90a81d8" ], "spl_set_id": [ "70b562ea-9f21-4e4a-b3ed-0590b2892f6a" ], "package_ndc": [ "30698-007-01", "30698-011-01", "30698-015-01", "30698-019-01", "30698-020-01", "30698-021-50" ], "unii": [ "1Y58DO4MY1" ] }, "products": [ { "product_number": "007", "reference_drug": "Yes", "brand_name": "NORPRAMIN", "active_ingredients": [ { "name": "DESIPRAMINE HYDROCHLORIDE", "strength": "10MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "005", "reference_drug": "Yes", "brand_name": "NORPRAMIN", "active_ingredients": [ { "name": "DESIPRAMINE HYDROCHLORIDE", "strength": "100MG" } ], "reference_standard": "Yes", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "003", "reference_drug": "Yes", "brand_name": "NORPRAMIN", "active_ingredients": [ { "name": "DESIPRAMINE HYDROCHLORIDE", "strength": "50MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "NORPRAMIN", "active_ingredients": [ { "name": "DESIPRAMINE HYDROCHLORIDE", "strength": "25MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "006", "reference_drug": "Yes", "brand_name": "NORPRAMIN", "active_ingredients": [ { "name": "DESIPRAMINE HYDROCHLORIDE", "strength": "150MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "004", "reference_drug": "Yes", "brand_name": "NORPRAMIN", "active_ingredients": [ { "name": "DESIPRAMINE HYDROCHLORIDE", "strength": "75MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" } ] } ] }