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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CBZR1400010 五味子糖浆 Oral solution Chinese Herbal Medicine State Standards 2014-07-01 湖南科伦制药有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2016-11-29 view
CXHB0500699 肌苷氯化钠注射液 inosine Injection Chemical Drugs Supplementary Application 2005-04-27 湖南科伦制药有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2005-09-23 view
CXHL0501483 注射用兰索拉唑 lansoprazole Lyophilized Chemical Drugs(3.3) New Drug Application 2005-09-04 湖南中南科伦药业有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2008-08-13 view
CXHL1100781 甘油磷酰胆碱注射液 choline alfoscerate Injection Chemical Drugs(3.1) New Drug Application 2012-05-16 湖南中南科伦药业有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2016-03-28 view
CXHL1200873 布洛芬注射液 ibuprofen Injection Chemical Drugs(3.3) New Drug Application 2013-05-03 湖南科伦制药有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2015-11-19 view
CXHL1301379 盐酸吉西他滨注射液 gemcitabine hydrochloride Injection Chemical Drugs(5) New Drug Application 2014-02-24 湖南科伦制药有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2016-12-08 view
CXHL1501299 盐酸右美托咪定注射液 dexmedetomidine hydrochloride Injection Chemical Drugs(3.4) New Drug Application 2015-09-06 湖南科伦制药有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2016-09-11 view
CXHL1501300 盐酸右美托咪定注射液 dexmedetomidine hydrochloride Injection Chemical Drugs(3.4) New Drug Application 2015-09-06 湖南科伦制药有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2016-09-11 view
CXHL1502146 注射用紫杉醇(白蛋白结合型) paclitaxel(albumin bound) Lyophilized Chemical Drugs(3.4) New Drug Application 2015-12-30 湖南科伦制药有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2017-07-06 view
CXHL1502147 注射用紫杉醇(白蛋白结合型) paclitaxel(albumin bound) Lyophilized Chemical Drugs(1.6) New Drug Application 2015-12-30 湖南科伦制药有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2017-07-06 view
CXHL2300610 盐酸鲁拉西酮口崩片 lurasidone hydrochloride Tablet Chemical Drugs(2.2) New Drug Application 2023-06-07 Hunan Kelun Pharmaceutical Co Ltd view
CXHL2401120 KLA480注射液 KLA-480 Injection Chemical Drugs(2.2) New Drug Application 2024-10-22 Hunan Kelun Pharmaceutical Co Ltd view
CXHL2500046 注射用KLA578-1 Chemical Drugs(2.2) New Drug Application 2025-01-09 Hunan Kelun Pharmaceutical Co Ltd view
CXHL2500449 KLA318-2纳米晶注射液 KLA318-2 Injection Chemical Drugs(2.2) New Drug Application 2025-05-09 Hunan Kelun Pharmaceutical Co Ltd view
CXHS0501102 注射用呋塞米 furosemide Lyophilized Chemical Drugs(5) New Drug Application 2005-07-10 湖南中南科伦药业有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2007-12-20 view
CXHS0502789 阿莫西林氟氯西林钠胶囊 amoxicillin;flucloxacillin magnesium Capsule Chemical Drugs(3.2) New Drug Application 2005-12-26 湖南中南科伦药业有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2008-02-29 view
CXHS0502965 盐酸托烷司琼氯化钠注射液 tropisetron hydrochloride Injection Chemical Drugs(4) New Drug Application 2006-06-22 湖南科伦制药有限公司 Hunan Kelun Pharmaceutical Co Ltd;Changsha Zexiang Medical Technology Co Ltd Certificate Issued 2010-03-11 view
CXHS0600660 注射用乳酸加替沙星 Gatifloxacin Lactate Lyophilized Chemical Drugs(5) New Drug Application 2006-09-14 湖南中南科伦药业有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2008-10-30 view
CXHS0600661 乳酸加替沙星注射液 Gatifloxacin Lactate Injection Chemical Drugs(5) New Drug Application 2006-09-14 湖南中南科伦药业有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2008-10-30 view
CXHS1000262 头孢地尼分散片 cefdinir Tablet Chemical Drugs(5) New Drug Application 2011-03-08 湖南中南科伦药业有限公司 Hunan Kelun Pharmaceutical Co Ltd Certificate Issued 2014-09-09 view