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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2200061 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(2.4) New Drug Application 2022-01-28 Betta Pharmaceuticals Co Ltd view
CXHL2200060 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(2.4) New Drug Application 2022-01-28 Betta Pharmaceuticals Co Ltd view
CXHS2101028 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(2.4) New Drug 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
CXHS2101029 盐酸恩沙替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(2.4) New Drug Application 2021-07-13 Betta Pharmaceuticals Co Ltd 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
CXHS1800046 盐酸恩莎替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(1) New Drug Application 2019-01-02 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2020-11-24 view
CXHS1800045 盐酸恩莎替尼胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(1) New Drug Application 2019-01-02 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2020-11-24 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
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
CXHL1502061 X-396胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(1.1) New Drug Application 2015-11-30 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2016-08-12 view
CXHL1502060 X-396胶囊 Ensartinib Hydrochloride Capsule Chemical Drugs(1.1) New Drug Application 2015-11-30 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd Certificate Issued 2016-08-12 view