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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXS01643 盐酸川芎嗪氯化钠注射液 Ligustrazine Hydrochloride Injection Chemical Drugs(4) New Drug Application 2001-12-07 深圳天一时科技开发有限公司南京京华生物工程有限公司 江苏苏中制药厂 Certificate Issued 2003-01-08 view
CXS20020496 门冬氨酸钾镁葡萄糖注射液 Magnesium aspartate;Potassium Aspartate Injection Chemical Drugs(4) New Drug Application 2004-04-09 南京京华生物工程有限公司淮安曌元药业有限公司 Certificate Issued 2005-02-21 view
CXS00450 注射用克林霉素磷酸酯 clindamycin phosphate Lyophilized Chemical Drugs(4) New Drug Application 2000-10-18 南京京华生物工程有限公司 南京金康制药有限公司 Certificate Issued 2001-09-04 view
CXL20020916 盐酸托烷司琼 tropisetron hydrochloride Active ingredient Chemical Drugs(4) New Drug Application 2002-05-20 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-08-25 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
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
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
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
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
CXL20021515 注射用醋酸奥曲肽 Octreotide acetate Lyophilized Chemical Drugs(4) New Drug Application 2002-06-24 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2004-01-14 view
CXL01G77 那格列奈 nateglinide 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 2003-08-18 view
X0303275 注射用雷替曲塞 raltitrexed Lyophilized Chemical Drugs(3.1) New Drug Application 2004-04-23 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2004-08-16 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
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
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
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
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
CXL01C88G 注射用加替沙星 gatifloxacin Lyophilized Chemical Drugs(2) New Drug Application 2002-02-28 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
CXL20021011 非那雄胺胶囊 finasteride Capsule Chemical Drugs(4) New Drug Application 2002-05-30 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-09-27 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