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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHL1600115 X-396胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(1) Import Drug Application 2016-10-13 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2017-05-31 view
JXHL1600114 X-396胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(1) Import Drug Application 2016-10-13 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2017-05-31 view
CYZB1606479 烧伤止痛膏 Ointment Chinese Herbal Medicine Supplementary Application 2016-10-13 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2018-07-24 view
CYZB0807357 烧伤止痛膏 Ointment Chinese Herbal Medicine Supplementary Application 2008-10-17 浙江贝达药业有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2009-04-24 view
CYHS1400149 阿托伐他汀钙片 atorvastatin calcium Tablet Chemical Drugs(6) Generic Drug 2014-07-24 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2016-02-04 view
CYHS1290046 苯磺酸氨氯地平片 amlodipine besylate Tablet Chemical Drugs(6) Generic Drug 2012-04-26 浙江贝达药业有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2016-03-10 view
CYHS1200795 缬沙坦胶囊 valsartan Capsule Chemical Drugs(6) Generic Drug 2013-04-28 浙江贝达药业有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2015-12-24 view
CYHS0900872 苯磺酸氨氯地平片 amlodipine besylate Tablet Chemical Drugs(6) Generic Drug 2009-12-07 浙江贝达药业有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2011-01-11 view
CYHB2101570 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(1) Supplementary Application 2021-07-13 Betta Pharmaceuticals Co Ltd view
CYHB2101569 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(1) Supplementary Application 2021-07-13 Betta Pharmaceuticals Co Ltd view
CYHB1402346 盐酸埃克替尼片 Icotinib Tablet Chemical Drugs Supplementary Application 2014-04-28 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2014-12-25 view
CYHB1311153 盐酸埃克替尼片 Icotinib Tablet Chemical Drugs Supplementary Application 2014-01-15 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2014-11-21 view
CXSL2400603 注射用MCLA-129 MCLA-129 Lyophilized Biological Products(1) New Drug Application 2024-09-11 Betta Pharmaceuticals Co Ltd view
CXSL2300322 注射用MCLA-129 MCLA-129 Lyophilized Biological Products(1) New Drug Application 2023-05-09 Betta Pharmaceuticals Co Ltd view
CXSL2200622 BPB-101双抗注射液 BPB-101 Injection Biological Products(1) New Drug Application 2022-12-29 Betta Pharmaceuticals Co Ltd view
CXSL2100011 MCLA-129注射液 MCLA-129 Injection Biological Products(1) New Drug Application 2021-01-09 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd In Review 2021-01-08 view
CXSB2200001 注射用MCLA-129 MCLA-129 Lyophilized Biological Products(1) Supplementary Application 2022-01-07 Betta Pharmaceuticals Co Ltd view
CXHS2400039 酒石酸泰贝西利胶囊 BPI-16350 Capsule Chemical Drugs(1) New Drug Application 2024-05-01 Betta Pharmaceuticals Co Ltd view
CXHS2300016 甲磺酸贝福替尼胶囊 Befotertinib Mesylate Capsule Chemical Drugs(1) New Drug Application 2023-01-20 Betta Pharmaceuticals Co Ltd view
CXHS2300015 甲磺酸贝福替尼胶囊 Befotertinib Mesylate Capsule Chemical Drugs(1) New Drug Application 2023-01-20 Betta Pharmaceuticals Co Ltd view