仿制药参比制剂目录（第五批）

1附件仿制药参比制剂目录（第五批）序号药品通用名称英文名称/商品名规格剂型持证商备注1备注251艾司唑仑片ESTAZOLAMTABLETS/EURODIN1MG片剂TEVATAKEDAYAKUHINLTD日本橙皮书52艾司唑仑片ESTAZOLAMTABLETS/EURODIN2MG片剂TEVATAKEDAYAKUHINLTD日本橙皮书53氨茶碱片AMINOPHYLLINETABLETS/NEOPHYLLIN01G（按C2H8N2（C7H8N4O2）22H2O计）片剂SANNOVACO,LTD日本橙皮书日本上市名称AMINOPHYLLINEHYDRATETABLETS54丙硫氧嘧啶片PROPYLTHIOURACILTABLETS/PROPYLTHIOURACIL50MG片剂DAVAPHARMACEUTICALSINC美国橙皮书55醋酸甲地孕酮片MEGESTROLACETATETABLETS/MEGACE016G片剂PHARMASWISSESKREPUBLIKASRO欧盟上市（产地英国）56地高辛片DIGOXINTABLETS/LANOXIN025MG片剂CONCORDIAPHARMACEUTICALSINC美国橙皮书57多潘立酮片DOMPERIDONETABLETS/MOTILIUM10MG片剂JANSSENCILAGVALDEREUILFRANCE欧盟上市（上市国家法国；产地法国）法国上市名称DOMPERIDONEFILMCOATEDTABLETS58奋乃静片PERPHENAZINETABLETS/PERPHENAZINE2MG片剂SANDOZINC美国橙皮书2序号药品通用名称英文名称/商品名规格剂型持证商备注1备注259奋乃静片PERPHENAZINETABLETS/PERPHENAZINE4MG片剂SANDOZINC美国橙皮书510复方地芬诺酯片COMPOUNDDIPHENOXYLATEHYDROCHLORIDETABLETS/LOMOTIL盐酸地芬诺酯25MG，硫酸阿托品25G片剂GDSEARLELLC美国橙皮书美国上市名称DIPHENOXYLATEHYDROCHLORIDEANDATROPINESULFATETABLETS511格列本脲片GLIBENCLAMIDETABLETS/DAONIL25MG片剂SANOFIKK日本橙皮书512枸橼酸他莫昔芬片TAMOXIFENCITRATETABLETS/NOLVADEX10MG（按他莫昔芬计）片剂ASTRAZENECAKK日本橙皮书513红霉素肠溶胶囊ERYTHROMYCINENTERICCAPSULES/ERYC025G（25万单位）胶囊剂MAYNEPHARMAINTERNATIONALPTYLTD美国橙皮书美国上市名称ERYTHROMYCINDELAYEDRELEASECAPSULES514红霉素肠溶片ERYTHROMYCINENTERICCOATEDTABLETS/ERYTAB025G（25万单位）片剂ARBORPHARMACEUTICALSLLC美国橙皮书美国上市名称ERYTHROMYCINDELAYEDRELEASETABLETS3序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2515琥珀酸亚铁片FERROUSSUCCINATETABLETS/INOFER01G片剂LABORATOIREDELINOFER欧盟上市（上市国家法国；产地法国）516华法林钠片WARFARINSODIUMTABLETS/COUMADIN25MG片剂BRISTOLMYERSSQUIBBPHARMACO美国橙皮书517华法林钠片WARFARINSODIUMTABLETS/COUMADIN5MG片剂BRISTOLMYERSSQUIBBPHARMACO美国橙皮书518己烯雌酚片DIETHYLSTILBESTROLTABLETS/DISTILBENE1MG片剂LABORATOIRESGERDA欧盟上市（上市国家法国；产地法国）519卡托普利片CAPTOPRILTABLETS/CAPTORIL125MG片剂DAIICHISANKYOESPHACO,LTD日本橙皮书520卡托普利片CAPTOPRILTABLETS/CAPTORIL25MG片剂DAIICHISANKYOESPHACO,LTD日本橙皮书521利培酮片RISPERIDONETABLETS/RISPERDAL1MG片剂JANSSENPHARMACEUTICALSINC美国橙皮书4序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2522利培酮片RISPERIDONETABLETS/RISPERDAL2MG片剂JANSSENPHARMACEUTICALSINC美国橙皮书523柳氮磺吡啶肠溶片SULFASALAZINEENTERICCOATEDTABLETS/AZULFIDINE025G片剂（肠溶片）PFIZERJAPANINC日本橙皮书日本上市名称SALAZOSULFAPYRIDINEENTERICCOATEDTABLETS524马来酸多潘立酮片DOMPERIDONEMALEATETABLETS/MOTILIUM10MG（按C22H24CLN5O2计）片剂JOHNSONJOHNSONCONSUMERNV/SABELGIUM欧盟上市（上市国家比利时；产地法国比利时上市名称DOMPERIDONEMALEATEFILMCOATEDTABLETS525麦角胺咖啡因片ERGOTAMINEANDCAFFEINETABLETS/CAFERGOT酒石酸麦角胺1MG，无水咖啡因100MG片剂SANDOZINC美国橙皮书美国上市名称ERGOTAMINETARTRATEANDCAFFEINETABLETS526蒙脱石散MONTMORILLONITEPOWDER/SMECTA3G散剂IPSENPHARMA欧盟上市（上市国家法国；产地法国）527米非司酮片MIFEPRISTONETABLETS/MIFEGYNE02G片剂EXELGYN欧盟上市（上市国家法国；产地法国）528诺氟沙星片NORFLOXACINTABLETS/BACCIDAL01G片剂KYORINPHARMACEUTICALCO,LTD日本橙皮书5序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2529氢化可的松片HYDROCORTISONETABLETS/CORTEF10MG片剂PHARMACIAANDUPJOHNCO美国橙皮书530氢化可的松片HYDROCORTISONETABLETS/CORTEF20MG片剂PHARMACIAANDUPJOHNCO美国橙皮书531舒必利片SULPIRIDETABLETS/ABILIT01G片剂DAINIPPONSUMITOMOPHARMACO,LTD日本橙皮书532舒必利片SULPIRIDETABLETS/ABILIT50MG片剂DAINIPPONSUMITOMOPHARMACO,LTD日本橙皮书533替加氟胶囊TEGAFURCAPSULES/FUTRAFUL02G胶囊剂TAIHOPHARMACEUTICALCO,LTD日本橙皮书534替硝唑片TINIDAZOLETABLETS/FASIGYN05G片剂PFIZERLIMITED欧盟上市上市国家英国；产地法国535硝酸异山梨酯片ISOSORBIDEDINITRATETABLETS/ISORDIL5MG片剂VALEANTPHARMACEUTICALSNORTHAMERICALLC美国橙皮书6序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2536盐酸地尔硫片DILTIAZEMHYDROCHLORIDETABLETS/HERBESSER30MG片剂MITSUBISHITANABEPHARMACORPORATION日本橙皮书537盐酸二甲双胍片METFORMINHYDROCHLORIDETABLETS/GLYCORAN025G片剂NIPPONSHINYAKUCO,LTD日本橙皮书538盐酸二甲双胍片METFORMINHYDROCHLORIDETABLETS/GLUCOPHAGE05G片剂MERCKSANTSAS欧盟上市（上市国家法国；产地法国）539盐酸雷尼替丁胶囊RANITIDINEHYDROCHLORIDECAPSULESRANITIDINEHYDROCHLORIDE015G（按C13H22N403S计）胶囊剂SANDOZINC美国橙皮书540盐酸雷尼替丁片RANITIDINEHYDROCHLORIDETABLETSZANTAC015G（按C13H22N403S计）片剂GLAXOSMITHKLINEUK欧盟上市（上市国家英国；产地德国）541盐酸美西律片MEXILETINEHYDROCHLORIDETABLETS/MEXILETINEHYDROCHLORIDE50MG片剂KYOWACRITICARECO,LTD日本橙皮书542盐酸美西律片MEXILETINEHYDROCHLORIDETABLETS/MEXILETINEHYDROCHLORIDE01G片剂KYOWACRITICARECO,LTD日本橙皮书7序号药品通用名称英文名称/商品名规格剂型持证商备注1备注2543盐酸帕罗西汀片PAROXETINEHYDROCHLORIDE/PAXIL20MG（按C19H20FNO3计）片剂APOTEXTECHNOLOGIESINC美国橙皮书544盐酸乙胺丁醇片ETHAMBUTOLHYDROCHLORIDETABLES/EBUTOL025G片剂KAKENPHARMACEUTICALCO,LTD日本橙皮书545异烟肼片ISONIAZIDTABLETS/ISONIAZID03G片剂SANDOZINC美国橙皮书546异烟肼片ISONIAZIDTABLETS/ISONIAZID01G片剂SANDOZINC美国橙皮书547盐酸普萘洛尔片PROPRANOLOLHYDROCHLOR