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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSL01009 重组人组织型纤溶酶原激酶衍生物 Recombinant Human Tissue-type Plasminogen Activator Derivative Lyophilized Biological Products(2) New Drug Application 2001-02-16 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-06-10 view
CSL01017 重组人淋巴毒素α衍生物 Other Biological Products(1) New Drug Application 2001-04-02 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-06-12 view
CZL20020191 桑根碱片 Tablet Chinese Herbal Medicine(2) New Drug Application 2004-03-12 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2005-01-10 view
X0304913 重组人甲状旁腺激素(1-34) parathyroid hormone Other Biological Products(7) New Drug Application 2004-04-20 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2004-08-16 view
X0303256 重组人白细胞介素-1受体拮抗剂 Other Biological Products(7) New Drug Application 2004-04-20 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2004-08-30 view
X0304871 外用盐酸氨酮戊酸 aminolevulinic acid hydrochloride Powder Chemical Drugs(3.1) New Drug Application 2004-06-02 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2004-08-30 view
X0304870 盐酸氨酮戊酸 aminolevulinic acid hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2004-06-02 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2004-08-30 view
X0405744 注射用重组人淋巴毒素α衍生物 Lyophilized Biological Products Supplementary Application 2004-10-12 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2005-11-17 view
X0306190 淡糖片 Tablet Chinese Herbal Medicine(5) New Drug Application 2004-11-08 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2005-02-25 view
X0402543 注射用海姆泊芬 hemoporfin Lyophilized Chemical Drugs(1.1) New Drug Application 2005-01-04 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd;Chinese PLA General Hospital Certificate Issued 2005-04-19 view
X0400427 重组人肿瘤坏死因子受体-Fc融合蛋白 Other Biological Products(7) New Drug Application 2005-01-04 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2005-05-12 view
X0402542 海姆泊芬 hemoporfin Active ingredient Chemical Drugs(1.1) New Drug Application 2005-01-04 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd;Chinese PLA General Hospital Certificate Issued 2005-04-19 view
Y0416837 盐酸多柔比星脂质体注射液 doxorubicin hydrochloride Injection Chemical Drugs(6) Generic Drug 2005-01-06 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2005-12-08 view
CYSB0500092 唐氏综合征产前筛查系统 Diagnostic reagent IVD Supplementary Application 2005-07-01 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd In Review 2005-06-30 view
CXHB0501326 外用盐酸氨酮戊酸散 aminolevulinic acid hydrochloride Powder Chemical Drugs Supplementary Application 2005-07-06 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2005-10-08 view
CXHL0502298 盐酸多柔比星脂质体注射液 doxorubicin hydrochloride Injection Chemical Drugs(3.4) New Drug Application 2005-12-12 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2006-12-12 view
CXHS0503246 外用盐酸氨酮戊酸散 aminolevulinic acid hydrochloride Powder Chemical Drugs(3.1) New Drug Application 2006-01-24 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2007-02-26 view
CXHS0503244 盐酸氨酮戊酸 aminolevulinic acid hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2006-01-24 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2007-02-26 view
CXHL0600010 注射用硫酸长春新碱脂质体浓溶液 vincristine sulfate Injection Chemical Drugs(5) New Drug Application 2006-02-24 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2009-03-09 view
CYHS0603579 注射用两性霉素B脂质体 amphotericin B Lyophilized Chemical Drugs(6) Generic Drug 2006-06-14 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Certificate Issued 2008-10-23 view