{ "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": "2026-07-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "20081222", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "24837", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020363s034ltr.pdf", "date": "20081224", "type": "Letter" }, { "id": "34551", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020363s034lbl.pdf", "date": "20090102", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "20060222", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "34549", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s026lbl.pdf", "date": "20060228", "type": "Label" }, { "id": "24835", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s026ltr.pdf", "date": "20060301", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "19951211", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "20120209", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "34552", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf", "date": "20120210", "type": "Label" }, { "id": "24840", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020363s038,s040ltr.pdf", "date": "20120213", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "20070606", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "19980612", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "2387", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf", "date": "19980612", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "19980612", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "2386", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf", "date": "19980612", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "20020806", "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": "19970917", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy" }, { "submission_type": "SUPPL", "submission_number": "10", "submission_status": "AP", "submission_status_date": "19980612", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "24833", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20363S14ltr.pdf", "date": "19980612", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "49", "submission_status": "AP", "submission_status_date": "20161209", "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": "19940629", "review_priority": "STANDARD", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity" }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "20160916", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "45318", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020363s047lbl.pdf", "date": "20160916", "type": "Label" }, { "id": "45345", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020363Orig1s047ltr.pdf", "date": "20160920", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "45", "submission_status": "AP", "submission_status_date": "20151019", "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": "19970113", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "37", "submission_status": "AP", "submission_status_date": "20110131", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "12479", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020363s037lbl.pdf", "date": "20110131", "type": "Label" }, { "id": "24839", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020363s037ltr.pdf", "date": "20110204", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19960729", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "27", "submission_status": "AP", "submission_status_date": "20060728", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "12477", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf", "date": "20060804", "type": "Label" }, { "id": "24836", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s027, 020363s028LTR.pdf", "date": "20060804", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "20140625", "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": "19960729", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "20010329", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "41300", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-363S-019_review.pdf", "date": "20040414", "type": "Review" }, { "id": "12476", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20363S19LBL.PDF", "date": "20010329", "type": "Label" }, { "id": "24834", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20363S19LTR.PDF", "date": "20010329", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "19990202", "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": "19941227", "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": "19980326", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "19970715", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "19970131", "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": "20161101", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "46", "submission_status": "AP", "submission_status_date": "20150910", "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": "20120209", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "12480", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020363s038s040lbl.pdf", "date": "20120210", "type": "Label" }, { "id": "2389", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020363s038,s040ltr.pdf", "date": "20120213", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "44", "submission_status": "AP", "submission_status_date": "20150514", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "19960426", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "20091224", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "51150", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_famciclovir_Original_WR.pdf", "date": "20090921", "type": "Pediatric Written Request" }, { "id": "51609", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_famciclovir_Amendment_1.pdf", "date": "20090921", "type": "Pediatric Amendment 1" }, { "id": "51610", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_famciclovir_Amendment_2.pdf", "date": "20090921", "type": "Pediatric Amendment 2" }, { "id": "51611", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_famciclovir_Amendment_3.pdf", "date": "20090921", "type": "Pediatric Amendment 3" }, { "id": "52927", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_Famciclovir_Clinpharm_BPCA.pdf", "date": "20090929", "type": "Pediatric Clinical Pharmacology Review" }, { "id": "52928", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/pediatric/020363_Famciclovir_Clinical_BPCA.pdf", "date": "19000101", "type": "Pediatric Medical Review" }, { "id": "12478", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020363s036lbl.pdf", "date": "20100112", "type": "Label" }, { "id": "24838", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020363s036ltr.pdf", "date": "20091231", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "20181218", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "56793", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020363s050lbl.pdf", "date": "20181219", "type": "Label" }, { "id": "56927", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020363Orig1s050ltr.pdf", "date": "20181221", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "20060728", "review_priority": "UNKNOWN", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "2388", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020363s027, 020363s028LTR.pdf", "date": "20060804", "type": "Letter" }, { "id": "34550", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020363s027s028lbl.pdf", "date": "20060804", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "20130424", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12481", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020363s042lbl.pdf", "date": "20130430", "type": "Label" }, { "id": "2390", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020363Orig1s042ltr.pdf", "date": "20130425", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "6", "submission_status": "AP", "submission_status_date": "19950908", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" } ], "application_number": "NDA020363", "sponsor_name": "NOVARTIS", "products": [ { "product_number": "002", "reference_drug": "Yes", "brand_name": "FAMVIR", "active_ingredients": [ { "name": "FAMCICLOVIR", "strength": "500MG **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": "003", "reference_drug": "Yes", "brand_name": "FAMVIR", "active_ingredients": [ { "name": "FAMCICLOVIR", "strength": "125MG **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": "001", "reference_drug": "Yes", "brand_name": "FAMVIR", "active_ingredients": [ { "name": "FAMCICLOVIR", "strength": "250MG **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" } ] } ] }