{ "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": "2026-07-14", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "37", "submission_status": "AP", "submission_status_date": "20130409", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "1757", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s037ltr.pdf", "date": "20130411", "type": "Letter" }, { "id": "34064", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s037lbl.pdf", "date": "20130416", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "19960412", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "20170426", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "48134", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s043lbl.pdf", "date": "20170427", "type": "Label" }, { "id": "48212", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019885Orig1s043ltr.pdf", "date": "20170502", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "20120118", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "1756", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019885s035,020125s012ltr.pdf", "date": "20120123", "type": "Letter" }, { "id": "34063", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s035lbl.pdf", "date": "20120123", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19930526", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "20150911", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11812", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019885s041lbl.pdf", "date": "20150914", "type": "Label" }, { "id": "1760", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019885Orig1s041ltr.pdf", "date": "20150914", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "20020722", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19790", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19885slr019ltr.pdf", "date": "20030730", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "19920507", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "20111014", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11808", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019885s033lbl.pdf", "date": "20111020", "type": "Label" }, { "id": "1755", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019885s033ltr.pdf", "date": "20111018", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "19990910", "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": "20031029", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "1753", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19885slr023,20125slr003ltr.pdf", "date": "20031105", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "19980225", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "19970702", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "19960703", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "19951102", "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": "20130923", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11810", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s038lbl.pdf", "date": "20130923", "type": "Label" }, { "id": "1758", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s038ltr.pdf", "date": "20130924", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19951120", "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": "20120921", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11809", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019885s036lbl.pdf", "date": "20120925", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "20090918", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11807", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019885s028lbl.pdf", "date": "20091001", "type": "Label" }, { "id": "1754", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019885s028ltr.pdf", "date": "20091112", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "20170213", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "47194", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019885Orig1s042ltr.pdf", "date": "20170214", "type": "Letter" }, { "id": "47216", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019885s042lbl.pdf", "date": "20170215", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "19941012", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "20140502", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "19791", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019885Orig1s040ltr.pdf", "date": "20140506", "type": "Letter" }, { "id": "34065", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019885s040lbl.pdf", "date": "20140506", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19931029", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "20010417", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "1752", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19885S18ltr.pdf", "date": "20010417", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "19980504", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "20021213", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "19970703", "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": "19911119", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity", "application_docs": [ { "id": "44038", "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm", "date": "20060609", "type": "Other Important Information from FDA" } ] }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "20010621", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "19970701", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "10", "submission_status": "AP", "submission_status_date": "19960618", "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": "20131025", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "11811", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019885s039lbl.pdf", "date": "20131031", "type": "Label" }, { "id": "1759", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019885Orig1s039ltr.pdf", "date": "20131028", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "19951101", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "45", "submission_status": "AP", "submission_status_date": "20200518", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "63153", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019885Orig1s045ltr.pdf", "date": "20200520", "type": "Letter" }, { "id": "83827", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019885Orig1s045lbl.pdf", "date": "20251020", "type": "Label" } ] } ], "application_number": "NDA019885", "sponsor_name": "PFIZER PHARMS", "products": [ { "product_number": "003", "reference_drug": "Yes", "brand_name": "ACCUPRIL", "active_ingredients": [ { "name": "QUINAPRIL HYDROCHLORIDE", "strength": "EQ 20MG BASE **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", "te_code": "AB" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "ACCUPRIL", "active_ingredients": [ { "name": "QUINAPRIL HYDROCHLORIDE", "strength": "EQ 5MG BASE **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", "te_code": "AB" }, { "product_number": "004", "reference_drug": "Yes", "brand_name": "ACCUPRIL", "active_ingredients": [ { "name": "QUINAPRIL HYDROCHLORIDE", "strength": "EQ 40MG BASE **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", "te_code": "AB" }, { "product_number": "002", "reference_drug": "Yes", "brand_name": "ACCUPRIL", "active_ingredients": [ { "name": "QUINAPRIL HYDROCHLORIDE", "strength": "EQ 10MG BASE **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", "te_code": "AB" } ] } ] }