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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS2101034 注射用CMAB007 omalizumab Lyophilized Biological Products(3.4) New Drug Application 2021-10-22 Taizhou Maibotaike Pharmaceutical Co Ltd 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
CXSS2101035 注射用CMAB007 omalizumab Lyophilized Biological Products(3.4) New Drug Application 2021-10-22 Taizhou Maibotaike Pharmaceutical Co Ltd view
CYSB2500028 注射用奥马珠单抗α omalizumab Lyophilized Biological Products Supplementary Application 2025-01-25 Taizhou Maibotaike Pharmaceutical Co Ltd view
CXSL2300378 注射用奥马珠单抗α omalizumab Lyophilized Biological Products(3.4) New Drug Application 2023-05-27 Taizhou Maibotaike Pharmaceutical Co Ltd view
CYSB2500080 注射用奥马珠单抗α omalizumab Lyophilized Biological Products Supplementary Application 2025-04-16 Taizhou Maibotaike Pharmaceutical Co Ltd 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
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
CYSB2500081 注射用奥马珠单抗α omalizumab Lyophilized Biological Products Supplementary Application 2025-04-16 Taizhou Maibotaike Pharmaceutical Co Ltd 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
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
CXSL2300377 注射用奥马珠单抗α omalizumab Lyophilized Biological Products(3.4) New Drug Application 2023-05-27 Taizhou Maibotaike Pharmaceutical Co Ltd view
JYSB2200072 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2022-04-19 Novartis Pharma Stein AG;Novartis Europharm Ltd view
JYSB2300136 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2023-08-15 Novartis Pharma Stein AG;Novartis Europharm Ltd view
JYSB2101108 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Supplementary Application 2021-08-18 Novartis Pharma Stein AG;Novartis Europharm Ltd view
CYSB2500027 注射用奥马珠单抗α omalizumab Lyophilized Biological Products Supplementary Application 2025-01-25 Taizhou Maibotaike Pharmaceutical Co Ltd view
JXSS1400005 注射用奥马珠单抗 omalizumab Lyophilized Biological Products Import Drug Application 2014-05-19 Novartis Europharm Limited Novartis Europharm Ltd;Novartis Pharma Stein AG Certificate Issued 2017-08-28 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
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