{ "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": "2026-08-21", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "20220427", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "70842", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208341s019lbl.pdf", "date": "20220428", "type": "Label" }, { "id": "70864", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208341Orig1s019ltr.pdf", "date": "20220429", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "20210610", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "submission_property_type": [ { "code": "Orphan" } ], "application_docs": [ { "id": "67767", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208341s017lbl.pdf", "date": "20210611", "type": "Label" }, { "id": "67774", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208341Orig1s017ltr.pdf", "date": "20210614", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "20171109", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "50376", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208341Orig1s009ltr.pdf", "date": "20171113", "type": "Letter" }, { "id": "50394", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s009lbl.pdf", "date": "20171113", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "20200714", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "63925", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208341s015lbl.pdf", "date": "20200715", "type": "Label" }, { "id": "63963", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208341Orig1s015ltr.pdf", "date": "20200720", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "20170831", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "49649", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s007lbl.pdf", "date": "20170901", "type": "Label" }, { "id": "49656", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208341Orig1s007ltr.pdf", "date": "20170901", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "20190919", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "60059", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208341Orig1s013ltr.pdf", "date": "20190920", "type": "Letter" }, { "id": "60070", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208341s013lbl.pdf", "date": "20190920", "type": "Label" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20160628", "review_priority": "PRIORITY", "submission_class_code": "TYPE 1/4", "submission_class_code_description": "Type 1 - New Molecular Entity and Type 4 - New Combination", "submission_property_type": [ { "code": "Orphan" } ], "application_docs": [ { "id": "40632", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208341s000lbl.pdf", "date": "20160628", "type": "Label" }, { "id": "44999", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208341Orig1s000TOC.html", "date": "20160628", "type": "Review" }, { "id": "32906", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208341Orig1s000ltr.pdf", "date": "20160628", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20170801", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "49211", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/0208341Orig1s001ltr.pdf", "date": "20170802", "type": "Letter" }, { "id": "49225", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s001lbl.pdf", "date": "20170803", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "20200319", "review_priority": "PRIORITY", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "submission_property_type": [ { "code": "Orphan" } ], "application_docs": [ { "id": "62208", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208341s014lbl.pdf", "date": "20200320", "type": "Label" }, { "id": "62213", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208341Orig1s014ltr.pdf", "date": "20200320", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "20221214", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "73571", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208341Orig1s020Corrected_ltr.pdf", "date": "20230221", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "20191115", "review_priority": "STANDARD", "submission_class_code": "EFFICACY", "submission_class_code_description": "Efficacy", "application_docs": [ { "id": "60886", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208341Orig1s012ltr.pdf", "date": "20191119", "type": "Letter" }, { "id": "60969", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208341s012lbl.pdf", "date": "20191119", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "20170214", "review_priority": "901 REQUIRED", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "47224", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208341Orig1s002ltr.pdf", "date": "20170215", "type": "Letter" }, { "id": "47251", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208341s002lbl.pdf", "date": "20170216", "type": "Label" } ] } ], "application_number": "NDA208341", "sponsor_name": "GILEAD SCIENCES INC", "openfda": { "application_number": [ "NDA208341" ], "brand_name": [ "EPCLUSA", "SOFOSBUVIR AND VELPATASVIR" ], "generic_name": [ "VELPATASVIR AND SOFOSBUVIR" ], "manufacturer_name": [ "Gilead Sciences, Inc.", "Asegua Therapeutics LLC" ], "product_ndc": [ "61958-2201", "61958-2203", "61958-2204", "61958-2205", "72626-2701" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "VELPATASVIR", "SOFOSBUVIR" ], "rxcui": [ "1799212", "1799218", "2288814", "2288816", "2584196", "2584199", "2584200", "2584201" ], "spl_id": [ "4e28b652-df20-450d-9f6e-4cc6e355e223", "314b9ef7-c6e5-44c9-9fbf-b0d35a24cd7d" ], "spl_set_id": [ "7f30631a-ee3b-4cfe-866b-964df3f0a44f", "d0c1a945-4440-4b5c-81aa-693ed3db597c" ], "package_ndc": [ "61958-2201-1", "61958-2203-1", "61958-2204-1", "61958-2205-1", "72626-2701-1" ], "nui": [ "N0000191256", "N0000190113", "N0000185503", "N0000190107", "N0000190108", "N0000190109", "N0000191493", "N0000191258" ], "pharm_class_epc": [ "Hepatitis C Virus NS5A Inhibitor [EPC]", "Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]" ], "pharm_class_moa": [ "Breast Cancer Resistance Protein Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]", "RNA Replicase Inhibitors [MoA]" ], "unii": [ "KCU0C7RS7Z", "WJ6CA3ZU8B" ] }, "products": [ { "product_number": "001", "reference_drug": "Yes", "brand_name": "EPCLUSA", "active_ingredients": [ { "name": "SOFOSBUVIR", "strength": "400MG" }, { "name": "VELPATASVIR", "strength": "100MG" } ], "reference_standard": "Yes", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription" }, { "product_number": "002", "reference_drug": "Yes", "brand_name": "EPCLUSA", "active_ingredients": [ { "name": "SOFOSBUVIR", "strength": "200MG" }, { "name": "VELPATASVIR", "strength": "50MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription" } ] } ] }