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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
CXS01684 头孢呋辛酯分散片 cefuroxime axetil Tablet Chemical Drugs(4) New Drug Application 2002-01-21 合肥康卫抗菌素研究所山东淄博新达制药有限公司 Certificate Issued 2003-11-28 view
FX20020035 头孢羟氨卡颗粒 cefadroxil Granule Chemical Drugs Generic Drug 2002-02-23 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-07-19 view
FX20020189 格列吡嗪胶囊 glipizide Capsule Chemical Drugs Generic Drug 2002-04-28 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-09-12 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
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
X0300546 盐酸吡格列酮胶囊 pioglitazone hydrochloride Capsule Chemical Drugs(1.1) New Drug Application 2003-02-09 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2003-10-29 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
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
X0305551 利福昔明胶囊 rifaximin Capsule Chemical Drugs(3.1) New Drug Application 2003-11-05 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2004-04-29 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
Y0304627 头孢羟氨苄片 cefadroxil Tablet Chemical Drugs(6) Generic Drug 2003-11-07 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2004-04-23 view
Y0304626 替硝唑片 tinidazole Tablet Chemical Drugs(6) Generic Drug 2003-11-07 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2004-04-23 view
X0306189 利福昔明片 rifaximin Tablet Chemical Drugs New Drug Application 2003-11-26 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Completed-Pending Issued 2004-01-13 view
Y0401559 盐酸环丙沙星片 ciprofloxacin hydrochloride Tablet Chemical Drugs(6) Generic Drug 2004-03-16 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2004-08-30 view
Y0402107 罗红霉素胶囊 roxithromycin Capsule Chemical Drugs(6) Generic Drug 2004-04-07 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2004-09-20 view