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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXL20021962-1 恩替卡韦片 entecavir Tablet Chemical Drugs(1) New Drug Application 2000-01-01 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd view
CXL20021962 恩替卡韦片 entecavir Tablet Chemical Drugs(1) New Drug Application 2002-08-13 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Certificate Issued 2003-02-28 view
CXL20021963 恩替卡韦片 entecavir Tablet Chemical Drugs(1) New Drug Application 2002-08-13 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Pending Approval 2002-10-11 view
CXLB20020087 恩替卡韦片 entecavir Tablet Chemical Drugs(1) New Drug Application 2002-10-17 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Approval Completed-Pending Certificated 2003-04-25 view
CXHS0500319 恩替卡韦片 entecavir Tablet Chemical Drugs New Drug Application 2005-02-25 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Certificate Issued 2005-11-23 view
CXHL0600258 马来酸恩替卡韦片 entecavir maleate Tablet Chemical Drugs(4) New Drug Application 2006-06-02 北京典范科技有限责任公司 Beijing Dianfan Technology Co Ltd Certificate Issued 2008-08-07 view
CXHB0601484 恩替卡韦片 entecavir Tablet Chemical Drugs Supplementary Application 2006-10-23 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Certificate Issued 2007-07-11 view
CXHB0701505 恩替卡韦片 entecavir Tablet Chemical Drugs Supplementary Application 2007-11-20 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Certificate Issued 2008-05-07 view
JXHL0800129 恩替卡韦片 entecavir Tablet Chemical Drugs Import Drug Application 2008-05-05 Bristol-Myers Squibb Company Certificate Issued 2009-11-23 view
CXHB0800326 恩替卡韦片 entecavir Tablet Chemical Drugs Supplementary Application 2008-05-27 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Certificate Issued 2008-12-22 view
CXHS0900348 马来酸恩替卡韦片 entecavir maleate Tablet Chemical Drugs(4) New Drug Application 2010-04-21 江苏正大天晴药业股份有限公司 Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd Certificate Issued 2012-06-13 view
CXHB1000301 恩替卡韦片 entecavir Tablet Chemical Drugs Supplementary Application 2010-08-25 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Certificate Issued 2011-02-12 view
CXHB1000300 恩替卡韦片 entecavir Tablet Chemical Drugs Supplementary Application 2010-08-25 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Certificate Issued 2011-02-12 view
CYHS1001269 恩替卡韦片 entecavir Tablet Chemical Drugs(6) Generic Drug 2011-03-18 重庆药友制药有限责任公司 Yaopharma Co Ltd Certificate Issued 2014-11-21 view
CYHS1001270 恩替卡韦片 entecavir Tablet Chemical Drugs(6) Generic Drug 2011-03-18 重庆药友制药有限责任公司 Yaopharma Co Ltd Certificate Issued 2014-11-21 view
CYHB1103064 恩替卡韦片 entecavir Tablet Chemical Drugs Supplementary Application 2011-05-16 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Certificate Issued 2011-11-07 view
CYHB1103063 恩替卡韦片 entecavir Tablet Chemical Drugs Supplementary Application 2011-05-16 中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd Certificate Issued 2011-11-07 view
CYHS1100294 恩替卡韦片 entecavir Tablet Chemical Drugs(6) Generic Drug 2011-06-13 珠海联邦制药股份有限公司中山分公司 Zhuhai United Laboratories Co Ltd Certificate Issued 2015-10-20 view
CYHS1100293 恩替卡韦片 entecavir Tablet Chemical Drugs(6) Generic Drug 2011-06-13 珠海联邦制药股份有限公司中山分公司 Zhuhai United Laboratories Co Ltd Certificate Issued 2015-10-20 view
CYHS1100493 恩替卡韦片 entecavir Tablet Chemical Drugs(6) Generic Drug 2011-06-29 浙江华圣生物药业有限公司 Zhejiang Huasheng Biopharmaceutical Co Ltd Certificate Issued 2016-08-23 view