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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHS2000348 盐酸伊伐布雷定片 ivabradine Tablet Chemical Drugs(4) Generic Drug 2020-06-02 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2021-12-20 view
CYHB2050712 注射用生长抑素 somatostatin Lyophilized Chemical Drugs Supplementary Application 2020-11-18 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Pending Approval 2021-12-20 view
CYHS2000347 盐酸伊伐布雷定片 ivabradine Tablet Chemical Drugs(4) Generic Drug 2020-06-02 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2021-12-20 view
CYHB2150049 注射用培美曲塞二钠 pemetrexed disodium Lyophilized Chemical Drugs(原6) Supplementary Application 2021-01-19 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2021-10-20 view
CYHB2150048 注射用培美曲塞二钠 pemetrexed disodium Lyophilized Chemical Drugs(原6) Supplementary Application 2021-01-19 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2021-10-20 view
CYHB2050290 酮咯酸氨丁三醇注射液 KETOROLAC TROMETHAMINE Injection Chemical Drugs Supplementary Application 2020-06-02 山东华鲁制药有限公司,山东新时代药业有限公司 Certificate Issued 2021-09-29 view
JTH2000369 美沙拉秦 mesalazine Active ingredient Chemical Drugs Disposable Import Drug Application 2020-12-14 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Pending Approval 2021-06-22 view
CYHB1950922 依托度酸胶囊 etodolac Capsule Chemical Drugs Supplementary Application 2020-01-01 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Pending Approval 2021-06-22 view
CYHS1900565 利伐沙班片 rivaroxaban Tablet Chemical Drugs(4) Generic Drug 2019-08-15 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2021-04-02 view
CYHB1950277 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs Supplementary Application 2019-04-15 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2021-03-25 view
CXSL2100063 注射用重组人源化抗BCMA/CD3双特异性抗体 Recombinant Humanized Anti-BCMA/CD3 Bis-specific Antibody Preparation Lyophilized Biological Products(1) New Drug Application 2021-02-27 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2021-02-26 view
CYHB2050208 米格列醇片 miglitol Tablet Chemical Drugs Supplementary Application 2020-04-22 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2021-01-21 view
CYHB1950283 酮咯酸氨丁三醇片 KETOROLAC TROMETHAMINE Tablet Chemical Drugs Supplementary Application 2019-04-15 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2021-01-15 view
CYHB2150030 盐酸法舒地尔注射液 fasudil hydrochloride Injection Chemical Drugs(原6) Supplementary Application 2021-01-13 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2021-01-12 view
CYHS2000929 注射用艾司奥美拉唑钠 esomeprazole sodium Lyophilized Chemical Drugs(4) Generic Drug 2020-12-28 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2020-12-25 view
CYHS2000865 盐酸沙丙蝶呤片 SAPROPTERIN HYDROCHLORIDE Tablet Chemical Drugs(4) Generic Drug 2020-12-10 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2020-12-09 view
CXSS2000058 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(3.4) New Drug Application 2020-11-27 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2020-11-26 view
CYHS2000656 盐酸二甲双胍缓释片 metformin hydrochloride Tablet, extended release Chemical Drugs(4) Generic Drug 2020-09-26 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2020-09-25 view
CYHS2000590 富马酸伏诺拉生片 vonoprazan fumarate Tablet Chemical Drugs(4) Generic Drug 2020-08-28 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2020-08-27 view
CYHS2000589 富马酸伏诺拉生片 vonoprazan fumarate Tablet Chemical Drugs(4) Generic Drug 2020-08-28 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2020-08-27 view