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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXL01G91 雷贝拉唑钠 rabeprazole sodium Active ingredient Chemical Drugs(2) New Drug Application 2001-12-24 清华紫光(集团)总公司清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Approval Completed-Pending Certificated 2003-01-21 view
CXL01G92 雷贝拉唑钠肠溶片 rabeprazole sodium Tablet Chemical Drugs(2) New Drug Application 2001-12-24 清华紫光(集团)总公司清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Approval Completed-Pending Certificated 2003-01-21 view
CXS20020300 氟尿嘧啶氯化钠注射液 fluorouracil Injection Chemical Drugs(4) New Drug Application 2002-04-28 湖南广维医药科技投资有限公司清华紫光古汉生物制药股份有限公司 Certificate Issued 2004-06-23 view
CXS20020442 注射用乳酸左氧氟沙星 Levofloxacin Lactate Lyophilized Chemical Drugs(4) New Drug Application 2002-06-03 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2003-06-20 view
CXS20020670 氯雷他定片 loratadine Tablet Chemical Drugs(4) New Drug Application 2002-08-01 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2004-07-12 view
X0301120 注射用左卡尼汀 levocarnitine Lyophilized Chemical Drugs(5) New Drug Application 2003-03-11 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2004-12-16 view
Y0300577 氟康唑注射液 fluconazole Injection Chemical Drugs(6) Generic Drug 2003-03-11 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2003-11-03 view
X0401473 注射用乳酸左氧氟沙星 Levofloxacin Lactate Lyophilized Chemical Drugs Supplementary Application 2004-03-30 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2004-07-29 view
X0301275 阿昔洛韦葡萄糖注射液 aciclovir Injection Chemical Drugs(5) New Drug Application 2004-05-31 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2005-01-31 view
X0405181 加替沙星葡萄糖注射液 gatifloxacin Injection Chemical Drugs New Drug Application 2004-09-13 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2005-02-04 view
Y0410981 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs(6) Generic Drug 2004-09-27 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2005-04-13 view
Y0415236 静脉注射用人免疫球蛋白(PH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2004-12-02 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2006-01-20 view
Y0415235 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2004-12-02 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2006-02-05 view
Y0415234 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2004-12-02 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2006-02-05 view
Y0415233 人免疫球蛋白 human immunoglobulin Injection Biological Products Supplementary Application 2004-12-02 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2006-01-20 view
Y0416633 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2004-12-30 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2005-12-09 view
Y0416466 人免疫球蛋白 human immunoglobulin Injection Biological Products Supplementary Application 2004-12-30 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2006-08-02 view
X0408374 氨酪酸氯化钠注射液 aminobutyric acid Injection Chemical Drugs(5) New Drug Application 2005-01-12 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2005-09-20 view
CXHS0501110 甲磺酸帕珠沙星注射液 pazufloxacin mesylate Injection Chemical Drugs(3.1) New Drug Application 2005-07-10 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2006-05-29 view
CXHS0501108 注射用甲磺酸帕珠沙星 pazufloxacin mesylate Lyophilized Chemical Drugs(3.1) New Drug Application 2005-07-10 清华紫光古汉生物制药股份有限公司 TUS- Pharmaceutical Group Co Ltd Certificate Issued 2006-06-21 view