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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXL00396 扎来普隆 zaleplon Active ingredient Chemical Drugs(2) New Drug Application 2000-12-08 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 view
CXS00719 头孢克罗泡腾片 cefaclor Tablet Chemical Drugs(4) New Drug Application 2000-12-19 龙泉市辰龙药业有限公司安徽省新星药物开发有限责任公司 Certificate Issued 2002-07-08 view
CXS00718 头孢克罗泡腾片 cefaclor Tablet Chemical Drugs(4) New Drug Application 2000-12-19 龙泉市辰龙药业有限公司安徽省新星药物开发有限责任公司 Certificate Issued 2002-07-08 view
CXL00397 扎来普隆胶囊 zaleplon Capsule Chemical Drugs(2) New Drug Application 2001-01-18 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 view
CXL01032 盐酸安非他酮缓释片 bupropion hydrochloride Tablet, extended release Chemical Drugs(2) New Drug Application 2001-02-08 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd In Approval view
CXL01031 盐酸安非他酮 bupropion hydrochloride Active ingredient Chemical Drugs(2) New Drug Application 2001-02-08 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 view
CXL01566 复方盐酸伪麻黄碱缓释片 naproxen sodium;PSEUDOEPHEDRINE HYDROCHLORIDE Tablet, extended release Chemical Drugs(4) New Drug Application 2001-07-27 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2002-05-27 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
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
CXS20020200 盐酸阿奇霉素 Azithromycin Hydrochloride Active ingredient Chemical Drugs(4) New Drug Application 2002-04-01 安徽省新星药物开发有限责任公司北京隆源同达医药研究所有限公司 南京长澳制药有限公司 Certificate Issued 2003-07-21 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
CXS20020201 注射用盐酸阿奇霉素 Azithromycin Hydrochloride Lyophilized Chemical Drugs(4) New Drug Application 2002-04-01 安徽省新星药物开发有限责任公司北京隆源同达医药研究所有限公司 南京长澳制药有限公司 Certificate Issued 2003-07-21 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 Certificate Issued 2004-02-09 view
CXL20022490 尼美舒利缓释片 nimesulide Tablet, extended release Chemical Drugs(4) New Drug Application 2003-08-14 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
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
X0302044 甲磺酸帕珠沙星注射液 pazufloxacin mesylate Injection Chemical Drugs(3.1) New Drug Application 2003-11-25 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2004-03-19 view
X0302045 甲磺酸帕珠沙星氯化钠注射液 pazufloxacin mesylate Injection Chemical Drugs(3.1) New Drug Application 2003-11-25 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2004-03-19 view
X0302043 甲磺酸帕珠沙星 pazufloxacin mesylate Active ingredient Chemical Drugs(3.1) New Drug Application 2003-11-25 安徽省新星药物开发有限责任公司 Anhui New Star Pharmaceutical Development Co Ltd Certificate Issued 2004-03-19 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