{ "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": 21 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "20200413", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "62557", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020789s036lbl.pdf", "date": "20200414", "type": "Label" }, { "id": "62558", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020789s036lbl.pdf#page=25", "date": "20200414", "type": "Medication Guide" }, { "id": "62563", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020789Orig1s036ltr.pdf", "date": "20200414", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "20160406", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "35380", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020789s034lbl.pdf", "date": "20160407", "type": "Label" }, { "id": "3378", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020789Orig1s034ltr.pdf", "date": "20160408", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "20100419", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13449", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf", "date": "20100420", "type": "Label" }, { "id": "3376", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020789s024,s026ltr.pdf", "date": "20100421", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "20131011", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "20100419", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "35377", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf", "date": "20100420", "type": "Label" }, { "id": "25852", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020789s024,s026ltr.pdf", "date": "20100421", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "20110923", "review_priority": "UNKNOWN", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "25853", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020789s030ltr.pdf", "date": "20110927", "type": "Letter" }, { "id": "35379", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020789s030lbl.pdf", "date": "20110929", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "20020515", "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": "20090423", "review_priority": "N/A", "submission_class_code": "REMS", "submission_class_code_description": "REMS", "application_docs": [ { "id": "35376", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf", "date": "20090513", "type": "Label" }, { "id": "3374", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020789s022,s025ltr.pdf", "date": "20090504", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "5", "submission_status": "AP", "submission_status_date": "20021007", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13447", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20789s5lbl.pdf", "date": "20021007", "type": "Label" }, { "id": "3371", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20789slr005ltr.pdf", "date": "20021007", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "20120126", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "13448", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf", "date": "20120131", "type": "Label" }, { "id": "25851", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020789s012ltr.pdf", "date": "20120130", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "3", "submission_status": "AP", "submission_status_date": "20011128", "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": "20030822", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "25850", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20789scm001ltr.pdf", "date": "20030828", "type": "Letter" }, { "id": "35373", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20789scm001_zonegran_lbl.pdf", "date": "20030828", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "20110527", "review_priority": "N/A", "submission_class_code": "REMS", "submission_class_code_description": "REMS", "application_docs": [ { "id": "3377", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020789s029ltr.pdf", "date": "20110531", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "20061120", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3372", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020789s019ltr.pdf", "date": "20061204", "type": "Letter" }, { "id": "35374", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020789s019lbl.pdf", "date": "20061122", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "20151112", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "20090423", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3375", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020789s022,s025ltr.pdf", "date": "20090504", "type": "Letter" }, { "id": "35378", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf", "date": "20090513", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "20020613", "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": "20000327", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity", "application_docs": [ { "id": "41708", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020789_Zonegran.html", "date": "20000327", "type": "Review" }, { "id": "44073", "url": "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100190.htm", "date": "20120203", "type": "Other Important Information from FDA" }, { "id": "13446", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20789lbl.pdf", "date": "20000327", "type": "Label" }, { "id": "25849", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20789ltr.pdf", "date": "20000327", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "20020401", "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": "20150619", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "3373", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020789Orig1s021ltr.pdf", "date": "20150622", "type": "Letter" }, { "id": "35375", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020789s021lbl.pdf", "date": "20150714", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "20020206", "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": "20001204", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" } ], "application_number": "NDA020789", "sponsor_name": "ADVANZ PHARMA", "products": [ { "product_number": "001", "reference_drug": "Yes", "brand_name": "ZONEGRAN", "active_ingredients": [ { "name": "ZONISAMIDE", "strength": "100MG" } ], "reference_standard": "Yes", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "002", "reference_drug": "Yes", "brand_name": "ZONEGRAN", "active_ingredients": [ { "name": "ZONISAMIDE", "strength": "50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**" } ], "reference_standard": "No", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Discontinued" }, { "product_number": "003", "reference_drug": "Yes", "brand_name": "ZONEGRAN", "active_ingredients": [ { "name": "ZONISAMIDE", "strength": "25MG" } ], "reference_standard": "No", "dosage_form": "CAPSULE", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" } ] } ] }