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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
Y0301660 肌苷口服溶液 inosine Oral solution Biological Products Supplementary Application 2003-06-12 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2003-11-03 view
Y0301662 肌苷口服溶液 inosine Oral solution Biological Products Supplementary Application 2003-06-12 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2003-11-03 view
Y0301661 肌苷口服溶液 inosine Oral solution Biological Products Supplementary Application 2003-06-12 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2003-11-03 view
X0302903 盐酸雷尼替丁氯化钠注射液 ranitidine hydrochloride Injection Chemical Drugs(5) New Drug Application 2003-06-17 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2004-02-13 view
Y0303078 葡萄糖氯化钠注射液 glucose;sodium chloride Injection Chemical Drugs Supplementary Application 2003-09-10 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2004-02-09 view
Y0303077 葡萄糖注射液 glucose Injection Chemical Drugs Supplementary Application 2003-09-10 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2004-01-17 view
Y0303216 葡萄糖注射液 glucose Injection Chemical Drugs Supplementary Application 2003-09-10 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2004-01-17 view
Y0303079 葡萄糖氯化钠注射液 glucose;sodium chloride Injection Chemical Drugs Supplementary Application 2003-09-10 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2004-02-09 view
X0305228 磷酸川芎嗪葡萄糖注射液 ligustrazine phosphate Injection Chemical Drugs(5) New Drug Application 2003-10-08 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2004-06-11 view
X0305079 乌拉地尔葡萄糖注射液 urapidil Injection Chemical Drugs(5) New Drug Application 2003-12-12 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2004-08-16 view
X0400115 盐酸氨溴索葡萄糖注射液 ambroxol hydrochloride Injection Chemical Drugs(5) New Drug Application 2004-01-12 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2004-08-16 view
X0400318 复方盐酸二甲双胍胶囊 glibenclamide;metformin hydrochloride Capsule Chemical Drugs New Drug Application 2004-02-02 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2004-08-16 view
X0402988 硝酸甘油软膏 glyceryl trinitrate Ointment Chemical Drugs(5) New Drug Application 2004-06-03 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2005-11-23 view
Y0405732 灭菌注射用水 STERILE WATER Injection Chemical Drugs Supplementary Application 2004-07-29 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2004-12-03 view
Y0408136 乳酸环丙沙星滴眼液 Ciprofloxacin Lactate Eye drops Chemical Drugs(6) Generic Drug 2004-08-20 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2005-05-13 view
Y0409607 庆大霉素普鲁卡因维B12颗粒(无糖型) cyanocobalamin;Gentamicin Sulfate;procaine hydrochloride Granule Chemical Drugs Supplementary Application 2004-08-26 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Filed 2004-06-11 view
Y0410359 乳酸左氧氟沙星注射液 Levofloxacin Lactate Injection Chemical Drugs(6) Generic Drug 2004-09-16 浙江平湖莎普爱思制药有限公司 Zhejiang Shapuaisi Pharmaceutical Co Ltd Certificate Issued 2005-05-09 view