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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHS1900020 他达拉非片 tadalafil Tablet Chemical Drugs(4) Generic Drug 2019-01-29 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2021-02-03 view
CXHL1500952 帕伯克利胶囊 palbociclib Capsule Chemical Drugs(3.1) New Drug Application 2015-06-05 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-08-12 view
CYHB1705294 依达拉奉注射液 edaravone Injection Chemical Drugs Supplementary Application 2017-08-30 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2018-06-15 view
CXHL1401419 依帕列净片 empagliflozin Tablet Chemical Drugs(3.1) New Drug Application 2014-10-11 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-03-25 view
CYHB1501059 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs Supplementary Application 2015-03-13 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-05-12 view
CXHL1401593 吸入用盐酸氨溴索溶液 ambroxol hydrochloride Inhalation Chemical Drugs(3.3) New Drug Application 2014-12-31 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-03-10 view
CXHS2000047 替戈拉生片 tegoprazan Tablet Chemical Drugs(1) New Drug Application 2021-01-14 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd In Review 2022-01-19 view
CXHL1401304 盐酸普拉格雷片 prasugrel hydrochloride Tablet Chemical Drugs(3.1) New Drug Application 2014-10-31 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-03-25 view
CYHS1900828 注射用福沙匹坦双葡甲胺 fosaprepitant dimeglumine Lyophilized Chemical Drugs(3) Generic Drug 2019-12-21 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd In Review 2019-12-19 view
CXHL1500958 富马酸沃诺拉赞片 vonoprazan fumarate Tablet Chemical Drugs(3.1) New Drug Application 2015-07-07 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-08-12 view
CYHB1850207 头孢氨苄胶囊 cefalexin Capsule Chemical Drugs Supplementary Application 2018-09-28 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2019-06-05 view
CXHL1500279 阿格列汀盐酸二甲双胍片 alogliptin;metformin hydrochloride Tablet Chemical Drugs(3.2) New Drug Application 2015-04-02 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-05-31 view
CYHS1400878 甲磺酸达比加群酯胶囊 dabigatran etexilate mesylate Capsule Chemical Drugs(6) Generic Drug 2015-02-03 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-02-18 view
CYHB2050459 注射用头孢美唑钠 cefmetazole sodium Lyophilized Chemical Drugs(原6) Supplementary Application 2020-08-01 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2021-09-23 view
CXHL1502501 SCC-31 SCC-31 Active ingredient Chemical Drugs(1.1) New Drug Application 2016-02-16 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-09-04 view
CXHL1401418 依帕列净 empagliflozin Active ingredient Chemical Drugs(3.1) New Drug Application 2014-10-11 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-03-25 view
CYHB1850469 辛伐他汀片 simvastatin Tablet Chemical Drugs Supplementary Application 2019-01-02 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2020-01-22 view
CXHL1500655 奥拉帕尼 olaparib Active ingredient Chemical Drugs(3.1) New Drug Application 2015-05-15 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-08-04 view
CXHL1600317 LXI-15028片 tegoprazan Tablet Chemical Drugs(1) New Drug Application 2016-12-30 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2017-07-06 view
CXHL1401859 盐酸美金刚缓释胶囊 memantine hydrochloride Capsules, extended release Chemical Drugs(5) New Drug Application 2015-02-28 山东罗欣药业集团股份有限公司 Shandong Luoxin Pharmaceutical Group STOCK Co Ltd Certificate Issued 2016-10-11 view