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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1301178 马来酸阿法替尼 Afatinib Dimaleate Active ingredient Chemical Drugs(3.1) New Drug Application 2013-12-17 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-01-21 view
CXHL1300994 马来酸阿塞那平舌下膜 asenapine maleate Film Chemical Drugs(3.1) New Drug Application 2013-12-17 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-03-11 view
CXHL1300993 马来酸阿塞那平舌下膜 asenapine maleate Film Chemical Drugs(3.1) New Drug Application 2013-12-17 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-03-11 view
CXHL1300992 马来酸阿塞那平 asenapine maleate Active ingredient Chemical Drugs(3.1) New Drug Application 2013-12-17 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-02-29 view
CXHL1301179 阿法替尼片 Afatinib Dimaleate Tablet Chemical Drugs(3.1) New Drug Application 2013-12-17 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-01-21 view
CXHL1301180 阿法替尼片 Afatinib Dimaleate Tablet Chemical Drugs(3.1) New Drug Application 2013-12-17 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-01-21 view
CXHL1300526 阿昔替尼片 axitinib Tablet Chemical Drugs(3.1) New Drug Application 2013-06-28 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2015-08-11 view
CXHL1300525 阿昔替尼片 axitinib Tablet Chemical Drugs(3.1) New Drug Application 2013-06-28 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2015-08-11 view
CXHL1300524 阿昔替尼 axitinib Active ingredient Chemical Drugs(3.1) New Drug Application 2013-06-28 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2015-08-11 view
CXSL1500052 重组抗表皮生长因子受体(EGFR)人鼠嵌合单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-07-20 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-09-28 view
CXSL1500053 重组抗表皮生长因子受体(EGFR)人鼠嵌合单克隆抗体注射液 Injection Biological Products(2) New Drug Application 2015-07-20 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-09-28 view
CXHL1300851 醋酸巴多昔芬片 bazedoxifene acetate Tablet Chemical Drugs(3.1) New Drug Application 2013-09-17 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-01-14 view
CXHL1300850 醋酸巴多昔芬 bazedoxifene acetate Active ingredient Chemical Drugs(3.1) New Drug Application 2013-09-17 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-01-14 view
CXHL1401522 索非布韦片 Sofosbuvir Tablet Chemical Drugs(3.1) New Drug Application 2014-11-13 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-03-25 view
CXHL1401521 索非布韦 Sofosbuvir Active ingredient Chemical Drugs(3.1) New Drug Application 2014-11-13 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2016-03-25 view
CXHL1400710 盐酸普拉克索缓释片 pramipexole dihydrochloride Tablet, extended release Chemical Drugs(5) New Drug Application 2014-07-11 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2015-12-15 view
CXHL1400709 盐酸普拉克索缓释片 pramipexole dihydrochloride Tablet, extended release Chemical Drugs(5) New Drug Application 2014-07-11 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2015-12-15 view
CXHL1400708 盐酸普拉克索缓释片 pramipexole dihydrochloride Tablet, extended release Chemical Drugs(5) New Drug Application 2014-07-11 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2015-12-15 view
CXHL1400707 盐酸普拉克索缓释片 pramipexole dihydrochloride Tablet, extended release Chemical Drugs(5) New Drug Application 2014-07-11 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2015-12-15 view
CXHL1400711 盐酸普拉克索缓释片 pramipexole dihydrochloride Tablet, extended release Chemical Drugs(5) New Drug Application 2014-07-11 四川科伦药物研究院有限公司 Sichuan Kelun Pharmacy Institute Co Ltd Certificate Issued 2015-12-15 view