{ "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": "2026-10-23", "results": { "skip": 0, "limit": 1, "total": 43 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "19961010", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "75", "submission_status": "AP", "submission_status_date": "20110225", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "67", "submission_status": "AP", "submission_status_date": "20080118", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "81", "submission_status": "AP", "submission_status_date": "20130130", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "73", "submission_status": "AP", "submission_status_date": "20090406", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "65", "submission_status": "AP", "submission_status_date": "20070625", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "57", "submission_status": "AP", "submission_status_date": "20050518", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "71", "submission_status": "AP", "submission_status_date": "20090624", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "49", "submission_status": "AP", "submission_status_date": "20040325", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "39", "submission_status": "AP", "submission_status_date": "20000628", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "53", "submission_status": "AP", "submission_status_date": "20040714", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "51", "submission_status": "AP", "submission_status_date": "20040315", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "19970603", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "88", "submission_status": "AP", "submission_status_date": "20181018", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "27", "submission_status": "AP", "submission_status_date": "19980403", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "20020417", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19871022", "review_priority": "PRIORITY", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity" }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "19950913", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "19980917", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "86", "submission_status": "AP", "submission_status_date": "20160726", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "19970926", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "78", "submission_status": "AP", "submission_status_date": "20110610", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "92", "submission_status": "AP", "submission_status_date": "20211111", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "19980917", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "90", "submission_status": "AP", "submission_status_date": "20200305", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "19940721", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "68", "submission_status": "AP", "submission_status_date": "20081003", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "82", "submission_status": "AP", "submission_status_date": "20130814", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "21", "submission_status": "AP", "submission_status_date": "19960911", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "74", "submission_status": "AP", "submission_status_date": "20111115", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "19940721", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "80", "submission_status": "AP", "submission_status_date": "20111018", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "70", "submission_status": "AP", "submission_status_date": "20090427", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "48", "submission_status": "AP", "submission_status_date": "20040315", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "62", "submission_status": "AP", "submission_status_date": "20060619", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "54", "submission_status": "AP", "submission_status_date": "20040714", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "60", "submission_status": "AP", "submission_status_date": "20051109", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "38", "submission_status": "AP", "submission_status_date": "20000830", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "52", "submission_status": "AP", "submission_status_date": "20050107", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "20000628", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "20040315", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "89", "submission_status": "AP", "submission_status_date": "20190503", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "19961122", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "95", "submission_status": "AP", "submission_status_date": "20240920", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "79687", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019537s095,020780s050lbl.pdf", "date": "20240923", "type": "Label" }, { "id": "79688", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019537s095,020780s050lbl.pdf#page=40", "date": "20240923", "type": "Medication Guide" }, { "id": "79713", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019537Orig1s095; 020780Orig1s050ltr.pdf", "date": "20240924", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "20000628", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "87", "submission_status": "AP", "submission_status_date": "20170726", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "20000628", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "79", "submission_status": "AP", "submission_status_date": "20110803", "review_priority": "N/A", "submission_class_code": "REMS", "submission_class_code_description": "REMS" }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "19930122", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "93", "submission_status": "AP", "submission_status_date": "20210330", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "85", "submission_status": "AP", "submission_status_date": "20160914", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "91", "submission_status": "AP", "submission_status_date": "20200508", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "19970515", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "19980917", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "69", "submission_status": "AP", "submission_status_date": "20090213", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "83", "submission_status": "AP", "submission_status_date": "20150202", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" } ], "application_number": "NDA019537", "sponsor_name": "BAYER HLTHCARE", "openfda": { "application_number": [ "NDA019537" ], "brand_name": [ "CIPRO" ], "generic_name": [ "CIPROFLOXACIN HYDROCHLORIDE" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-754", "50419-758", "50419-777", "50419-773" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CIPROFLOXACIN HYDROCHLORIDE" ], "rxcui": [ "197511", "205769", "205770", "213224", "213226", "309308", "309309", "309310" ], "spl_id": [ "1b112839-6cf0-466a-9188-86fc5b1549f9" ], "spl_set_id": [ "888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0" ], "package_ndc": [ "50419-758-01", "50419-754-01", "50419-777-01", "50419-773-01" ], "unii": [ "4BA73M5E37" ] }, "products": [ { "product_number": "004", "reference_drug": "Yes", "brand_name": "CIPRO", "active_ingredients": [ { "name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "EQ 750MG 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" }, { "product_number": "002", "reference_drug": "Yes", "brand_name": "CIPRO", "active_ingredients": [ { "name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "EQ 250MG BASE" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "003", "reference_drug": "Yes", "brand_name": "CIPRO", "active_ingredients": [ { "name": "CIPROFLOXACIN HYDROCHLORIDE", "strength": "EQ 500MG BASE" } ], "reference_standard": "Yes", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" } ] } ] }