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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXL99222 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs New Drug Application 2000-01-01 江苏苏中制药厂 Jiangsu Suzhong Pharmaceutical Factory In Review view
CXS00642 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs(4) New Drug Application 2000-10-19 江苏苏中制药厂 Jiangsu Suzhong Pharmaceutical Factory Certificate Issued 2002-04-01 view
CXb01554 硫酸阿米卡星氯化钠注射液 Amikacin sulfate Injection Chemical Drugs(4) Supplementary Application 2001-11-19 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2002-05-17 view
CXb01553 硫酸阿米卡星氯化钠注射液 Amikacin sulfate Injection Chemical Drugs(4) Supplementary Application 2001-11-19 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2002-05-17 view
CXB20020031 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs Supplementary Application 2002-01-15 江苏扬子江药业集团公司 Yangtze River Pharmaceutical (Group) Co Ltd Certificate Issued 2002-05-08 view
FX20020052 注射用硫酸阿米卡星 Amikacin sulfate Lyophilized Chemical Drugs Generic Drug 2002-02-23 上海第一生化药业公司上海第一制药厂 SPH NO1 Biochemical & Pharmaceutical Co Ltd Approval Completed-Pending Certificated view
CXb20020582 硫酸阿米卡星氯化钠注射液 Amikacin sulfate Injection Chemical Drugs(4) Supplementary Application 2002-09-05 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2003-05-09 view
Y0300290 注射用硫酸阿米卡星 Amikacin sulfate Lyophilized Chemical Drugs Supplementary Application 2003-02-24 苏州医药集团有限公司 Suzhou Pharmaceutical Group Co Ltd Certificate Issued 2003-11-07 view
Y0300291 注射用硫酸阿米卡星 Amikacin sulfate Lyophilized Chemical Drugs Supplementary Application 2003-02-24 苏州医药集团有限公司 Suzhou Pharmaceutical Group Co Ltd Certificate Issued 2003-11-07 view
Y0302132 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs(6) Generic Drug 2003-08-06 河南神农制药厂 Henan Shennong Pharmaceutical Co Ltd Certificate Issued 2004-02-13 view
FX20010395 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs Generic Drug 2003-08-21 福建小兴源集团(莆田)药业有限公司 Fujian Xingyuan Group (Putian) Medjgne Co Ltd Approval Completed-Pending Certificated 2003-12-12 view
Y0300456 注射用硫酸阿米卡星 Amikacin sulfate Lyophilized Chemical Drugs(6) Generic Drug 2003-09-29 海口奇力制药有限公司 Haikou Qili Pharmaceutical Co Ltd Certificate Issued 2004-02-09 view
Y0300457 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs(6) Generic Drug 2003-09-29 海口奇力制药有限公司 Haikou Qili Pharmaceutical Co Ltd Certificate Issued 2004-02-13 view
Y0302430 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs(6) Generic Drug 2004-02-02 陕西省秦光制药厂 Shaanxi Qinguang Pharmaceutical Factory Certificate Issued 2004-05-21 view
Y0302428 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs(6) Generic Drug 2004-02-02 陕西省秦光制药厂 Shaanxi Qinguang Pharmaceutical Factory Certificate Issued 2004-05-21 view
Y0305699 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs(6) Generic Drug 2004-07-27 华北制药集团制剂有限公司 North China Pharmaceutical Group Preparation Co Ltd Certificate Issued 2005-01-31 view
Y0305041 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs(6) Generic Drug 2004-08-12 福州福兴医药有限公司 Livzon Group Fuzhou Fuxing Pharmaceutical Co Ltd Certificate Issued 2004-12-16 view
Y0408585 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs(6) Generic Drug 2004-08-20 江苏鹏鹞药业有限公司 Jiangsu Pengyao Pharmaceutical Co Ltd Certificate Issued 2005-09-07 view
CYHB0501027 硫酸阿米卡星注射液 Amikacin sulfate Injection Chemical Drugs Supplementary Application 2005-08-09 湖南中南科伦药业有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2006-02-08 view
CYHS0504845 注射用硫酸阿米卡星 Amikacin sulfate Lyophilized Chemical Drugs(6) Generic Drug 2005-08-31 海南豪创药业有限公司 Hainan Yishun Pharmaceutical Co Ltd Certificate Issued 2006-06-02 view