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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXS00415 西沙必利胶囊 cisapride Capsule Chemical Drugs(4) New Drug Application 2000-12-08 济南高新开发区未来医药科贸中心,山东淄博新达制药有限公司 Certificate Issued 2002-10-28 view
CXS01021 乳酸司氟沙星片 Sparfloxacin Lactate Tablet Chemical Drugs(4) New Drug Application 2001-01-31 济南高新开发区未来医药科贸中心山东淄博新达制药有限公司 Certificate Issued 2005-07-28 view
CXS20020794 盐酸氯雷他定胶囊 Loratadine Hydrochloride Capsule Chemical Drugs(4) New Drug Application 2002-09-02 山东诚创医药技术开发有限公司山东淄博新达制药有限公司 Certificate Issued 2004-04-16 view
CXS20020995 盐酸多奈哌齐胶囊 donepezil hydrochloride Capsule Chemical Drugs(4) New Drug Application 2002-10-29 山东诚创医药技术开发有限公司山东淄博新达制药有限公司 Certificate Issued 2003-08-25 view
CXS00547 阿昔洛韦咀嚼片 aciclovir Tablet Chemical Drugs(4) New Drug Application 2000-09-29 山东诚创医药技术开发有限公司 山东淄博新达制药有限公司 Certificate Issued 2002-03-22 view
CXS00548 阿昔洛韦咀嚼片 aciclovir Tablet Chemical Drugs(4) New Drug Application 2000-09-29 山东诚创医药技术开发有限公司 山东淄博新达制药有限公司 Approval Completed-Pending Certificated 2002-03-14 view
CXS20020522 地红霉素肠溶胶囊 dirithromycin Capsule Chemical Drugs(2) New Drug Application 2002-07-10 山东省医药工业研究所 山东淄博新达制药有限公司 Certificate Issued 2003-06-20 view
CXS01500 阿昔洛韦葡萄糖注射液 aciclovir Injection Chemical Drugs(4) New Drug Application 2003-08-06 山东淄博新达制药有限公司 山东新华制药股份有限公司 Certificate Issued 2004-05-14 view
CYHS1201041 盐酸二甲双胍肠溶片 metformin hydrochloride Tablet Chemical Drugs(6) Generic Drug 2013-05-22 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2015-12-30 view
CXHL0502038 尼美舒利缓释片 nimesulide Tablet, extended release Chemical Drugs(5) New Drug Application 2006-01-05 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2007-05-11 view
X0300555 头孢克洛缓释片 cefaclor Tablet, extended release Chemical Drugs(5) New Drug Application 2003-09-23 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2004-04-02 view
CYHS1301906 头孢地尼胶囊 cefdinir Capsule Chemical Drugs(6) Generic Drug 2015-01-06 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2016-02-18 view
CXHB0801440 头孢克肟胶囊 cefixime Capsule Chemical Drugs Supplementary Application 2008-11-19 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2009-04-21 view
Y0403683 阿莫西林胶囊 amoxicillin Capsule Chemical Drugs Supplementary Application 2004-06-03 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2004-10-29 view
CYHS1200040 头孢克肟颗粒 cefixime Granule Chemical Drugs(6) Generic Drug 2012-06-19 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2015-10-20 view
CYHS0504036 盐酸环丙沙星片 ciprofloxacin hydrochloride Tablet Chemical Drugs(6) Generic Drug 2005-06-10 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2006-04-04 view
CYHB1390018 头孢呋辛酯分散片 cefuroxime axetil Tablet Chemical Drugs Supplementary Application 2013-09-18 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2014-08-26 view
CYHB0700906 头孢氨苄甲氧苄啶胶囊 cefalexin;trimethoprim Capsule Chemical Drugs Supplementary Application 2007-08-27 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2008-06-04 view
X0305763 地红霉素肠溶胶囊 dirithromycin Capsule Chemical Drugs Supplementary Application 2003-11-07 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2004-04-02 view
CXHL1000582 非布索坦片 febuxostat Tablet Chemical Drugs(3.1) New Drug Application 2011-03-07 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2015-07-01 view