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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0300479 厄多司坦 erdosteine Active ingredient Chemical Drugs(3.1) New Drug Application 2003-02-09 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2003-09-05 view
X0300480 厄多司坦片 erdosteine Tablet Chemical Drugs(3.1) New Drug Application 2003-02-09 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2003-09-05 view
X0300054 苯甲酸利扎曲普坦片 rizatriptan benzoate Tablet Chemical Drugs(3.1) New Drug Application 2003-08-08 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Completed-Pending Issued 2003-11-19 view
X0300053 苯甲酸利扎曲普坦 rizatriptan benzoate Active ingredient Chemical Drugs(3.1) New Drug Application 2003-08-08 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Completed-Pending Issued 2003-11-19 view
Y0302675 阿奇霉素胶囊 azithromycin Capsule Chemical Drugs(6) Generic Drug 2003-08-13 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2003-11-24 view
Y0302643 阿奇霉素片 azithromycin Tablet Chemical Drugs(6) Generic Drug 2003-08-13 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2003-11-24 view
Y0302674 阿奇霉素胶囊 azithromycin Capsule Chemical Drugs(6) Generic Drug 2003-08-13 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2003-11-24 view
Y0302272 阿奇霉素片 azithromycin Tablet Chemical Drugs(6) Generic Drug 2003-08-06 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2003-11-24 view
X0300057 甲磺酸帕苏沙星氯化钠注射液 pazufloxacin mesylate Injection Chemical Drugs(3.1) New Drug Application 2003-08-08 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Completed-Pending Issued 2003-11-25 view
X0300056 甲磺酸帕苏沙星注射液 pazufloxacin mesylate Injection Chemical Drugs(3.1) New Drug Application 2003-08-08 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Completed-Pending Issued 2003-11-25 view
X0300055 甲磺酸帕苏沙星 pazufloxacin mesylate Active ingredient Chemical Drugs(3.1) New Drug Application 2003-08-08 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Completed-Pending Issued 2003-11-25 view
X0300058 甲磺酸帕苏沙星氯化钠注射液 pazufloxacin mesylate Injection Chemical Drugs(3.1) New Drug Application 2003-08-08 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2003-12-05 view
X0302773 利拉萘酯 liranaftate Active ingredient Chemical Drugs(3.1) New Drug Application 2003-06-05 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2004-01-14 view
X0302774 利拉萘酯软膏 liranaftate Ointment Chemical Drugs(3.1) New Drug Application 2003-06-05 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2004-01-14 view
X0302786 注射用甲磺酸帕珠沙星 pazufloxacin mesylate Lyophilized Chemical Drugs(3.1) New Drug Application 2003-06-05 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2004-02-02 view
X0302063 盐酸多奈哌齐 donepezil hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2003-04-22 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2004-02-06 view
X0304359 头孢克洛缓释胶囊 cefaclor Capsules, extended release Chemical Drugs Supplementary Application 2003-08-22 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2004-02-13 view
X0400637 咪喹莫特软膏 imiquimod Ointment Chemical Drugs New Drug Application 2004-02-16 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2004-03-05 view
X0400636 咪喹莫特 imiquimod Active ingredient Chemical Drugs(2) New Drug Application 2004-02-16 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2004-03-05 view
X0305681 复方硝酸益康唑软膏 Econazole Nitrate;Triamcinolone acetonide Ointment Chemical Drugs Supplementary Application 2003-11-05 江苏扬子江药业集团有限公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Completed-Pending Issued 2004-03-12 view