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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXS00684 司帕沙星注射液 sparfloxacin Injection Chemical Drugs(4) New Drug Application 2000-11-24 四川省乐山市三民药物研究所 苏州长征-欣凯制药有限公司 Pending Approval 2002-07-23 view
CXb01191 阿奇霉素注射液 azithromycin Injection Chemical Drugs(4) Supplementary Application 2001-06-05 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2001-11-12 view
CXS01601 匹多莫德口服溶液 pidotimod Oral solution Chemical Drugs(4) New Drug Application 2001-11-19 天津市蓝恒医药化工技术研究所苏州长征制药厂 苏州长征-欣凯制药有限公司 Certificate Issued 2003-05-30 view
CXS01600 匹多莫德口服溶液 pidotimod Oral solution Chemical Drugs(4) New Drug Application 2001-11-19 天津市蓝恒医药化工技术研究所 苏州长征制药厂 苏州长征-欣凯制药有限公司 Certificate Issued 2003-05-30 view
FX20010345 硫酸奈替米星注射液 netilmicin sulfate Injection Chemical Drugs Generic Drug 2001-11-20 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-08-29 view
FX20010346 硫酸奈替米星注射液 netilmicin sulfate Injection Chemical Drugs Generic Drug 2001-11-20 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-08-29 view
CXb20020065 盐酸左氧氟沙星氯化钠注射液 Levofloxacin Hydrochloride Injection Chemical Drugs(4) Supplementary Application 2002-02-22 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2002-10-16 view
CXb20020064 阿奇霉素注射液 azithromycin Injection Chemical Drugs(4) Supplementary Application 2002-02-22 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2002-08-23 view
BFX20020020 氧氟沙星注射液 ofloxacin Injection Chemical Drugs Generic Drug 2002-02-23 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
BFX20020290 利巴韦林注射液 ribavirin Injection Chemical Drugs Generic Drug 2002-07-19 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-11-26 view
CXb20020579 盐酸左氧氟沙星注射液 Levofloxacin Hydrochloride Injection Chemical Drugs(4) Supplementary Application 2002-09-05 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2003-01-29 view
FX20020633 门冬氨基酸钾镁注射液 Magnesium aspartate;Potassium Aspartate Injection Chemical Drugs Generic Drug 2002-10-18 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-07-08 view
Y0301383 阿奇霉素片 azithromycin Tablet Chemical Drugs(6) Generic Drug 2003-05-16 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2003-10-10 view
X0300373 加替沙星注射液 gatifloxacin Injection Chemical Drugs(5) New Drug Application 2003-10-24 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2004-02-13 view
X0300374 加替沙星注射液 gatifloxacin Injection Chemical Drugs(5) New Drug Application 2003-10-24 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2004-02-13 view
Y0304441 氧氟沙星注射液 ofloxacin Injection Chemical Drugs Supplementary Application 2003-11-05 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2004-04-09 view
X0305867 螺旋霉素片 spiramycin Tablet Chemical Drugs(4) New Drug Application 2003-11-13 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2004-07-09 view
Y0305589 葛根素注射液 Puerarin Injection Chemical Drugs(6) Generic Drug 2003-12-17 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2004-10-12 view
Y0400925 利巴韦林片 ribavirin Tablet Chemical Drugs Supplementary Application 2004-02-18 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2004-07-02 view
Y0401145 尼莫地平注射液 nimodipine Injection Chemical Drugs(6) Generic Drug 2004-02-29 苏州长征-欣凯制药有限公司 Suzhou Changzheng-xinkai Pharmaceutical Co Ltd Certificate Issued 2004-09-17 view