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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CXL01E52G 非那雄胺片 finasteride Tablet Chemical Drugs(4) New Drug Application 2002-05-22 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-09-27 view
CXL01E51G 非那雄胺 finasteride Active ingredient Chemical Drugs(4) New Drug Application 2002-05-22 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2003-09-27 view
X0303276 雷替曲塞 raltitrexed Active ingredient 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
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
CXL01E50G 醋酸奥曲肽注射液 Octreotide acetate Injection Chemical Drugs(4) New Drug Application 2002-07-10 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2004-02-03 view
CXL01E49G 醋酸奥曲肽 Octreotide acetate Active ingredient Chemical Drugs(4) New Drug Application 2002-07-10 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd Certificate Issued 2004-01-14 view
CXL01G79 那格列奈胶囊 nateglinide 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 2003-08-18 view
CXL01G78 那格列奈片 nateglinide 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 2003-08-18 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
CXZL0500207 莲必治氯化钠注射液 Injection Chinese Herbal Medicine(7) New Drug Application 2005-04-22 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd In Review 2006-10-19 view
CXL20020918 盐酸托烷司琼胶囊 tropisetron hydrochloride Capsule 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 2003-09-19 view
CXL20020917 盐酸托烷司琼片 tropisetron hydrochloride Tablet 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 2003-09-19 view
CXL20020919 盐酸托烷司琼注射液 tropisetron hydrochloride Injection 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
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
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
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
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
CXZL0500205 注射用莲必治 Lyophilized Chinese Herbal Medicine(7) New Drug Application 2005-04-21 南京京华生物工程有限公司 Nanjing Jinghua Biological Engineering Co Ltd In Review 2006-10-19 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