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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXL01680 依西美坦 exemestane Active ingredient Chemical Drugs(2) New Drug Application 2001-08-07 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Approval Completed-Pending Certificated 2003-04-04 view
CXL01681 依西美坦片 exemestane Tablet Chemical Drugs(2) New Drug Application 2001-08-07 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Approval Completed-Pending Certificated 2003-04-04 view
CXL01682 依西美坦胶囊 exemestane Capsule Chemical Drugs(2) New Drug Application 2001-08-07 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Approval Completed-Pending Certificated 2003-04-04 view
CXL01G57 利塞膦酸钠 risedronate sodium Active ingredient Chemical Drugs(2) New Drug Application 2001-12-14 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-04-21 view
CXL01G58 利塞膦酸钠片 risedronate sodium Tablet Chemical Drugs(2) New Drug Application 2001-12-14 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-04-21 view
CXL01G59 利塞膦酸钠胶囊 risedronate sodium Capsule Chemical Drugs(2) New Drug Application 2001-12-14 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-04-21 view
CXL01G60 加替沙星氯化钠注射液 gatifloxacin Injection Chemical Drugs(2) New Drug Application 2001-12-14 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-04-21 view
CXL01G80 加替沙星注射液 gatifloxacin Injection Chemical Drugs(2) New Drug Application 2001-12-14 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Approval Completed-Pending Certificated 2003-02-13 view
CXL01C89G 加替沙星葡萄糖注射液 gatifloxacin Injection Chemical Drugs(2) New Drug Application 2001-12-14 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-10-17 view
CXL01A67G 吡嘧司特钾 pemirolast potassium Active ingredient Chemical Drugs(2) New Drug Application 2001-10-19 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-04-21 view
CXL20022110 吡嘧司特钾滴眼液 pemirolast potassium Eye drops Chemical Drugs(2) New Drug Application 2002-09-02 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-05-16 view
CXL01A68G 吡嘧司特钾片 pemirolast potassium Tablet Chemical Drugs(2) New Drug Application 2001-10-19 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-04-21 view
CXL01K07 吡嘧司特钾胶囊 pemirolast potassium Capsule Chemical Drugs(2) New Drug Application 2001-12-31 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Approval Completed-Pending Certificated 2003-04-03 view
CXL01G61 咪喹莫特 imiquimod Active ingredient Chemical Drugs(2) New Drug Application 2001-12-14 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Approval Completed-Pending Certificated 2003-03-03 view
CXL01G62 咪喹莫特软膏 imiquimod Ointment Chemical Drugs(2) New Drug Application 2001-12-14 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Approval Completed-Pending Certificated 2003-03-03 view
CXL20020821 复方盐酸二甲双胍胶囊 glibenclamide;metformin hydrochloride Capsule Chemical Drugs(4) New Drug Application 2002-04-28 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Approval Completed-Pending Certificated 2003-01-30 view
CXL01G75 多西他赛 docetaxel Active ingredient Chemical Drugs(4) New Drug Application 2003-12-24 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2004-05-28 view
CXL01G76 多西他赛注射液 docetaxel Injection Chemical Drugs(4) New Drug Application 2003-12-24 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2004-05-28 view
CXHL1000160 奥美拉唑碳酸氢钠胶囊 omeprazole;Sodium bicarbonate Capsule Chemical Drugs(3.2) New Drug Application 2010-06-23 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2012-07-10 view
CXHL1000159 奥美拉唑碳酸氢钠胶囊 omeprazole;Sodium bicarbonate Capsule Chemical Drugs(3.2) New Drug Application 2010-06-23 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2014-07-02 view