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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0600028 注射用重组人尿激酶原 recombinant human pro-urokinase Lyophilized Biological Products(1) New Drug Application 2006-03-13 上海天士力药业有限公司 Shanghai Tasly Pharmaceutical Co Ltd Certificate Issued 2006-11-29 view
CXSS0700070 注射用重组人尿激酶原 recombinant human pro-urokinase Lyophilized Biological Products New Drug Application 2008-02-18 上海天士力药业有限公司 Shanghai Tasly Pharmaceutical Co Ltd Certificate Issued 2011-04-15 view
CXSL1300034 注射用重组人尿激酶原 recombinant human pro-urokinase Lyophilized Biological Products(1) New Drug Application 2013-10-15 上海天士力药业有限公司 Shanghai Tasly Pharmaceutical Co Ltd Certificate Issued 2016-05-31 view
CXSL1400089 注射用重组人尿激酶原 recombinant human pro-urokinase Lyophilized Biological Products(1) New Drug Application 2014-11-17 上海天士力药业有限公司 Shanghai Tasly Pharmaceutical Co Ltd Certificate Issued 2015-12-24 view
CXSL1500066 注射用重组人尿激酶原 recombinant human pro-urokinase Lyophilized Biological Products(1) New Drug Application 2015-08-20 上海天士力药业有限公司 Shanghai Tasly Pharmaceutical Co Ltd Certificate Issued 2016-11-17 view
CYSB1900006 注射用重组人尿激酶原 recombinant human pro-urokinase Lyophilized Biological Products Supplementary Application 2019-01-23 天士力生物医药股份有限公司 Shanghai Tasly Pharmaceutical Co Ltd Certificate Issued 2020-03-13 view
CXSL1900082 培重组人成纤维细胞生长因子21注射液 Injection Biological Products(1) New Drug Application 2019-08-01 天士力生物医药股份有限公司 Shanghai Tasly Pharmaceutical Co Ltd In Review 2019-07-30 view
CXSL2000019 重组全人源抗PCSK9单克隆抗体注射液 Injection Biological Products(1) New Drug Application 2020-02-14 天士力生物医药股份有限公司 Shanghai Tasly Pharmaceutical Co Ltd In Review 2020-02-13 view
CYSB2000040 注射用重组人尿激酶原 recombinant human pro-urokinase Lyophilized Biological Products Supplementary Application 2020-03-12 天士力生物医药股份有限公司 Shanghai Tasly Pharmaceutical Co Ltd In Review 2020-03-11 view
CXSS2100013 注射用重组人尿激酶原 recombinant human pro-urokinase Lyophilized Biological Products(2.2) New Drug Application 2021-02-03 天士力生物医药股份有限公司 Shanghai Tasly Pharmaceutical Co Ltd In Review 2021-02-02 view
CXSS2101040 注射用重组人尿激酶原 recombinant human pro-urokinase Lyophilized Biological Products(2.2) New Drug Application 2021-10-21 Shanghai Tasly Pharmaceutical Co Ltd view
CXSL2200226 B1962注射液 AP-505 Injection Biological Products(1) New Drug Application 2022-05-27 Shanghai Tasly Pharmaceutical Co Ltd view
CXSL2300469 B1344 注射液 B-1344 Injection Biological Products(1) New Drug Application 2023-07-12 Shanghai Tasly Pharmaceutical Co Ltd view
CXSS2400083 注射用重组人尿激酶原 recombinant human pro-urokinase Lyophilized Biological Products(2.2) New Drug Application 2024-08-07 Shanghai Tasly Pharmaceutical Co Ltd view