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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0407904 非诺贝特缓释片 fenofibrate Tablet, extended release Chemical Drugs(5) New Drug Application 2004-12-22 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2005-07-29 view
CXS20021042 非诺贝特分散片 fenofibrate Tablet Chemical Drugs(4) New Drug Application 2002-11-14 安徽省新星药物开发有限责任公司 大连天宇制药有限公司 Dalian Tianyu Pharmaceutical Co Ltd Certificate Issued 2004-02-09 view
CXHL1300427 醋酸艾司利卡西平片 eslicarbazepine acetate Tablet Chemical Drugs(3.1) New Drug Application 2013-06-28 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2015-12-30 view
CXHL1300426 醋酸艾司利卡西平片 eslicarbazepine acetate Tablet Chemical Drugs(3.1) New Drug Application 2013-06-20 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2015-12-24 view
CXHL1300425 醋酸艾司利卡西平 eslicarbazepine acetate Active ingredient Chemical Drugs(3.1) New Drug Application 2013-06-20 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2015-12-24 view
CXL20020540 酒石酸托特罗定缓释片 tolterodine tartrate Tablet, extended release Chemical Drugs(4) New Drug Application 2002-04-01 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Approval Completed-Pending Certificated 2003-03-11 view
CXL20021783 西替伪麻缓释片 cetirizine hydrochloride;pseudoephedrine hydrochloride Tablet, extended release Chemical Drugs(4) New Drug Application 2003-08-21 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2004-02-03 view
CXHL1200619 西多福韦注射液 cidofovir Injection Chemical Drugs(3.1) New Drug Application 2012-12-24 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2016-02-19 view
CXHL1200618 西多福韦 cidofovir Active ingredient Chemical Drugs(3.1) New Drug Application 2012-12-24 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2016-02-19 view
CXHL0601181 萘二磺酸乙乳胆铵胶囊 aclatonium napadisilate Capsule Chemical Drugs(3.1) New Drug Application 2007-01-17 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2010-11-02 view
CXHL0601180 萘二磺酸乙乳胆铵 aclatonium napadisilate Active ingredient Chemical Drugs(3.1) New Drug Application 2007-01-17 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2010-10-28 view
CXHL1000149 苹果酸阿莫曲坦片 Almotriptan malate Tablet Chemical Drugs(3.1) New Drug Application 2010-07-02 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2011-06-03 view
CXHL1100758 苹果酸阿莫曲坦片 Almotriptan malate Tablet Chemical Drugs(3.1) New Drug Application 2012-03-02 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2015-11-12 view
CXHL1100757 苹果酸阿莫曲坦 Almotriptan malate Active ingredient Chemical Drugs(3.1) New Drug Application 2012-03-02 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2015-11-12 view
CXHL1000148 苹果酸阿莫曲坦 Almotriptan malate Active ingredient Chemical Drugs(3.1) New Drug Application 2010-07-02 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2011-06-03 view
X0305561 羟乙基淀粉(200/0.5)乳酸钠林格注射液 Hydroxyethyl Starch 200/0.5;sodium lactate Injection Chemical Drugs(3.1) New Drug Application 2004-09-13 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2005-01-26 view
CXL01F14 羟乙基淀粉(200/0.5)氯化钠注射液 Hydroxyethyl Starch 200/0.5 Injection Chemical Drugs(4) New Drug Application 2001-12-07 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2003-11-28 view
CXL01F13 羟乙基淀粉(200/0.5) Hydroxyethyl Starch 200/0.5 Active ingredient Chemical Drugs(4) New Drug Application 2001-12-07 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2003-11-28 view
X0403068 美托法宗缓释片 Tablet, extended release Chemical Drugs(3.1) New Drug Application 2004-06-10 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2005-04-22 view
X0403067 美托法宗 Active ingredient Chemical Drugs(3.1) New Drug Application 2004-06-10 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2005-04-22 view