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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1900315 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(1) New Drug Application 2019-10-23 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2019-10-21 view
CXHL2000142 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) New Drug Application 2020-04-09 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2020-04-08 view
CXHL2000143 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) New Drug Application 2020-04-09 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2020-04-08 view
CXHS1800024 赞布替尼胶囊 zanubrutinib Capsule Chemical Drugs(1) New Drug Application 2018-08-29 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd Certificate Issued 2020-06-10 view
CXHS1800030 赞布替尼胶囊 zanubrutinib Capsule Chemical Drugs(1) New Drug Application 2018-10-24 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd Certificate Issued 2020-06-10 view
CXHL2000500 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) New Drug Application 2020-09-26 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2020-09-25 view
CXHL2000499 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) New Drug Application 2020-09-26 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2020-09-25 view
CXHL2000498 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) New Drug Application 2020-09-26 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2020-09-25 view
CXHL2000497 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) New Drug Application 2020-09-26 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2020-09-25 view
CXHS2000037 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) New Drug Application 2020-09-30 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2020-09-30 view
CXHL2000611 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) New Drug Application 2020-12-02 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2020-12-01 view
CXHL2100137 苹果酸Sitravatinib胶囊 sitravatinib malate Capsule Chemical Drugs(1) New Drug Application 2021-02-25 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2021-02-24 view
CXHL2100136 苹果酸Sitravatinib胶囊 sitravatinib malate Capsule Chemical Drugs(1) New Drug Application 2021-02-25 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2021-02-24 view
CXHB2100034 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(1) Supplementary Application 2021-03-04 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2021-03-04 view
CXHS2000021 帕米帕利胶囊 pamiparib Capsule Chemical Drugs(1) New Drug Application 2020-07-20 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd Certificate Issued 2021-05-11 view
CXHB2100038 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) Supplementary Application 2021-03-04 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2022-01-27 view
CXHB2100037 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) Supplementary Application 2021-03-04 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2022-01-27 view
CXHB2100036 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) Supplementary Application 2021-03-04 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2022-01-27 view
CXHB2100035 BGB-11417薄膜包衣片 Sonrotoclax Tablet Chemical Drugs(1) Supplementary Application 2021-03-04 百济神州(苏州)生物科技有限公司 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd In Review 2022-01-27 view