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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1500039 地特胰岛素注射液 insulin detemir Injection Biological Products(15) New Drug Application 2015-09-28 通化东宝药业股份有限公司 Tonghua Dongbao Pharmaceutical Co Ltd Certificate Issued 2017-10-17 view
CXSL1500040 地特胰岛素 insulin detemir Injection Biological Products(7) New Drug Application 2015-09-28 通化东宝药业股份有限公司 Tonghua Dongbao Pharmaceutical Co Ltd Certificate Issued 2017-10-17 view
CYSB1900292 地特胰岛素注射液 insulin detemir Injection Biological Products Supplementary Application 2019-08-15 诺和诺德(中国)制药有限公司 Novo Nordisk (China) Pharmaceuticals Co Ltd In Review 2019-08-14 view
CYSB2000154 地特胰岛素注射液 insulin detemir Injection Biological Products Supplementary Application 2020-06-19 诺和诺德(中国)制药有限公司 Novo Nordisk (China) Pharmaceuticals Co Ltd Certificate Issued 2021-07-22 view
CXSL1300085 地特胰岛素 insulin detemir Injection Biological Products(7) New Drug Application 2013-12-17 珠海联邦制药股份有限公司 Zhuhai United Laboratories Co Ltd Certificate Issued 2016-07-14 view
CXSL1300086 地特胰岛素注射液 insulin detemir Injection Biological Products(15) New Drug Application 2013-12-17 珠海联邦制药股份有限公司 Zhuhai United Laboratories Co Ltd Certificate Issued 2016-07-14 view
CXSL1300083 地特胰岛素注射液 insulin detemir Injection Biological Products(15) New Drug Application 2014-01-03 正大天晴药业集团股份有限公司 Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd Certificate Issued 2015-07-13 view
CXSL1300082 地特胰岛素 insulin detemir Injection Biological Products(7) New Drug Application 2014-01-03 正大天晴药业集团股份有限公司 Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd Certificate Issued 2015-07-13 view
CXSL1800007 地特胰岛素注射液 insulin detemir Injection Biological Products(15) New Drug Application 2018-02-06 杭州中美华东制药有限公司 Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd Certificate Issued 2018-11-09 view
CXSL1900092 地特胰岛素注射液 insulin detemir Injection Biological Products(15) New Drug Application 2019-08-28 华润昂德生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd In Review 2019-08-27 view
JXSL1200029 地特胰岛素 insulin detemir Injection Biological Products Import Drug Application 2012-04-28 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2015-04-08 view
JYSB2000197 地特胰岛素注射液 insulin detemir Injection Biological Products Supplementary Application 2020-05-18 丹麦诺和诺德公司 Novo Nordisk A/S Filed 2020-05-25 view
JYSB1400251 地特胰岛素注射液 insulin detemir Injection Biological Products Supplementary Application 2014-12-10 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2015-02-12 view
J0401805 地特胰岛素注射液 insulin detemir Injection Biological Products(7) Import Drug Application 2004-09-24 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2005-12-06 view
JYSZ1800047 地特胰岛素注射液 insulin detemir Injection Biological Products License Renew 2018-09-25 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2019-09-16 view
JYSB1100228 地特胰岛素注射液 insulin detemir Injection Biological Products Supplementary Application 2011-10-31 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2013-07-16 view
JYSB1800184 地特胰岛素注射液 insulin detemir Injection Biological Products Supplementary Application 2018-09-06 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2019-09-23 view
JXSS0800002 地特胰岛素注射液 insulin detemir Injection Biological Products(7) Import Drug Application 2008-02-18 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2009-07-01 view
JYSB1400250 地特胰岛素注射液 insulin detemir Injection Biological Products Supplementary Application 2014-12-10 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2015-02-12 view
JYSZ1800049 地特胰岛素注射液 insulin detemir Injection Biological Products License Renew 2018-09-25 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2019-09-16 view