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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1401941 BGB-3111 zanubrutinib Active ingredient Chemical Drugs(1.1) New Drug Application 2015-02-13 百济神州(北京)生物科技有限公司 BeiGene (Beijing) Co Ltd Certificate Issued 2016-03-11 view
CXHL1401948 BGB-3111胶囊 zanubrutinib Capsule Chemical Drugs(1.1) New Drug Application 2015-02-13 百济神州(北京)生物科技有限公司 BeiGene (Beijing) Co Ltd Certificate Issued 2016-03-11 view
CXHL1401942 BGB-3111胶囊 zanubrutinib Capsule Chemical Drugs(1.1) New Drug Application 2015-02-13 百济神州(北京)生物科技有限公司 BeiGene (Beijing) Co Ltd Certificate Issued 2016-03-11 view
CXHB2300047 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) Supplementary Application 2023-03-02 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd 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
CXHB2101014 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) Supplementary Application 2021-04-23 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CYHB2200296 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(1) Supplementary Application 2022-02-10 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CXHB2400070 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(1) Supplementary Application 2024-03-21 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd 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
CXHS2200007 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) New Drug Application 2022-01-28 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CXHB2200027 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) Supplementary Application 2022-03-03 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CYHS2200112 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(3) Generic Drug 2022-01-18 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CXHB2300246 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) Supplementary Application 2023-12-07 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd 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
CYHB2201181 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(1) Supplementary Application 2022-07-15 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CYHB2200307 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) Supplementary Application 2022-02-11 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CXHB2000019 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs Supplementary Application 2020-03-24 百济神州(北京)生物科技有限公司 BeiGene (Beijing) Co Ltd In Review 2020-03-23 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
CXHB2200070 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) Supplementary Application 2022-05-10 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view
CXHS2300057 泽布替尼胶囊 zanubrutinib Capsule Chemical Drugs(2.4) New Drug Application 2023-06-21 Baiji Shenzhou (Suzhou) Biotechnology Co Ltd view