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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL0500112 盐酸氨溴索口腔崩解片 ambroxol hydrochloride Tablet Chemical Drugs(5) New Drug Application 2005-02-17 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2005-08-24 view
CXHL0500388 美洛昔康口腔崩解片 meloxicam Tablet Chemical Drugs(5) New Drug Application 2005-03-26 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2005-12-06 view
CXHL0500900 甲磺酸酚妥拉明口腔崩解片 phentolamine mesylate Tablet Chemical Drugs(5) New Drug Application 2005-05-19 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2005-12-27 view
CXHL0501124 盐酸西替利嗪口腔崩解片 cetirizine hydrochloride Tablet Chemical Drugs(5) New Drug Application 2005-07-01 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2006-03-08 view
CXHL0501541 阿昔洛韦口腔崩解片 aciclovir Tablet Chemical Drugs(5) New Drug Application 2005-09-01 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2006-09-06 view
CXHL0502016 盐酸多奈哌齐口腔崩解片 donepezil hydrochloride Tablet Chemical Drugs(5) New Drug Application 2005-11-10 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2006-07-04 view
CXHL0502317 罗通定口腔崩解片 rotundine Tablet Chemical Drugs(5) New Drug Application 2005-12-27 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2006-09-06 view
CXHL0900447 复方奥美拉唑胶囊 omeprazole;Sodium bicarbonate Capsule Chemical Drugs(3.2) New Drug Application 2009-11-30 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2011-04-01 view
CXHL0900448 复方奥美拉唑胶囊 omeprazole;Sodium bicarbonate Capsule Chemical Drugs(3.2) New Drug Application 2009-11-30 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2011-04-01 view
CXHL0900599 双丙戊酸钠 divalproex sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2010-04-15 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2012-06-11 view
CXHL0900600 双丙戊酸钠肠溶片 divalproex sodium Tablet Chemical Drugs(3.1) New Drug Application 2010-04-15 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2012-06-11 view
CXHL1100122 阿戈美拉汀 agomelatine Active ingredient Chemical Drugs(3.1) New Drug Application 2011-07-27 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2015-07-01 view
CXHL1100123 阿戈美拉汀片 agomelatine Tablet Chemical Drugs(3.1) New Drug Application 2011-07-27 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2015-07-01 view
CXHL1301082 罗氟司特 roflumilast Active ingredient Chemical Drugs(3.1) New Drug Application 2014-01-09 山东方明药业集团股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2016-01-28 view
CXHL1301083 罗氟司特片 roflumilast Tablet Chemical Drugs(3.1) New Drug Application 2014-01-09 山东方明药业集团股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2016-01-21 view
CXHL1400485 布洛芬注射液 ibuprofen Injection Chemical Drugs(3.3) New Drug Application 2014-06-04 山东方明药业集团股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2016-02-29 view
CXHL1400486 布洛芬注射液 ibuprofen Injection Chemical Drugs(3.3) New Drug Application 2014-06-04 山东方明药业集团股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2016-02-29 view
CXHL1400792 左乙拉西坦缓释片 levetiracetam Tablet, extended release Chemical Drugs(5) New Drug Application 2014-07-07 山东方明药业集团股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2016-01-14 view
CXHS0502017 尼麦角林注射液 nicergoline Injection Chemical Drugs(5) New Drug Application 2005-09-01 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2008-08-22 view
CXHS0900236 盐酸西替利嗪口腔崩解片 cetirizine hydrochloride Tablet Chemical Drugs(5) New Drug Application 2009-12-16 山东方明药业股份有限公司 Shandong FANGMING Pharmaceutical Group Co Ltd Certificate Issued 2013-08-05 view