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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS2101035 注射用CMAB007 omalizumab Lyophilized Biological Products(3.4) New Drug Application 2021-10-22 Taizhou Maibotaike Pharmaceutical Co Ltd view
CXSS2101034 注射用CMAB007 omalizumab Lyophilized Biological Products(3.4) New Drug Application 2021-10-22 Taizhou Maibotaike Pharmaceutical Co Ltd view
JXSL0700004 注射用奥马珠单抗 omalizumab Lyophilized Biological Products(7) Import Drug Application 2007-01-26 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Schweiz AG Certificate Issued 2008-04-22 view
JYSB1900002 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2019-01-05 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd Certificate Issued 2019-01-29 view
CXSS2300047 注射用奥马珠单抗 omalizumab Lyophilized Biological Products(3.3) New Drug Application 2023-06-21 CSPC Megalith Biopharmaceutical Co Ltd view
JYSB1800082 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2018-04-19 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd Certificate Issued 2018-07-20 view
JYSB2000314 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2020-06-25 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd Filed 2020-07-01 view
CXSS2400143 注射用奥马珠单抗 omalizumab Lyophilized Biological Products(3.3) New Drug Application 2024-12-31 Thousand Oaks Biopharmaceuticals Co Ltd;Sichuan Yuanda Shuyang Pharmaceutical Co Ltd view
JYSB1800166 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2018-08-17 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd Certificate Issued 2018-10-29 view
JXSS2100003 注射用奥马珠单抗 omalizumab Lyophilized Biological Products(3.1) Import Drug Application 2021-01-14 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd In Review 2021-01-13 view
JYSB1800024 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2018-02-11 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Pharma Schweiz AG Certificate Issued 2018-07-30 view
JYSB1900223 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2019-09-04 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd Certificate Issued 2020-09-27 view
JYSZ2100529 注射用奥马珠单抗 omalizumab Lyophilized Biological Products License Renew 2021-09-07 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd view
CYSB2400286 注射用奥马珠单抗 omalizumab Lyophilized Biological Products(3.3) Supplementary Application 2024-10-31 CSPC Megalith Biopharmaceutical Co Ltd view
JYSB1800167 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2018-08-13 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd Certificate Issued 2018-10-29 view
JYSB2000557 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2020-11-04 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd Certificate Issued 2020-12-23 view
JXSL1400039 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Import Drug Application 2014-07-23 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Schweiz AG Certificate Issued 2016-03-18 view
JYSB1900049 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2019-02-15 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd Certificate Issued 2019-10-31 view
JYSB2200036 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2022-03-03 Novartis Pharma Stein AG;Novartis Europharm Ltd view
JYSB2000313 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2020-06-30 北京诺华制药有限公司 Beijing Novartis Pharma Co Ltd;Novartis Pharma Stein AG;Novartis Europharm Ltd In Review 2020-06-29 view