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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXS01438 格列美脲片 glimepiride Tablet Chemical Drugs(2) New Drug Application 2001-09-07 美国杰西企业有限公司 山东新华制药股份有限公司 Certificate Issued 2001-10-17 view
CXS01437 格列美脲 glimepiride Active ingredient Chemical Drugs(2) New Drug Application 2001-09-03 美国杰西企业有限公司 山东新华制药股份有限公司 Certificate Issued 2001-10-17 view
CXS01500 阿昔洛韦葡萄糖注射液 aciclovir Injection Chemical Drugs(4) New Drug Application 2003-08-06 山东淄博新达制药有限公司 山东新华制药股份有限公司 Certificate Issued 2004-05-14 view
CXL00407 尼索地平缓释胶囊 nisoldipine Capsules, extended release Chemical Drugs(4) New Drug Application 2001-01-18 山东新华制药股份有限公司,中国药科大学 Certificate Issued 2001-09-10 view
CXHS0503463 左氧氟沙星注射液 levofloxacin Injection Chemical Drugs(5) New Drug Application 2006-03-24 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2007-06-11 view
CXHL1200483 布洛芬注射液 ibuprofen Injection Chemical Drugs(3.3) New Drug Application 2012-09-14 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2015-10-29 view
Y0416173 盐酸纳洛酮注射液 naloxone hydrochloride Injection Chemical Drugs(6) Generic Drug 2004-12-22 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2005-08-03 view
CYHS0800822 苯巴比妥 phenobarbital Active ingredient Chemical Drugs(6) Generic Drug 2009-02-26 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2010-01-07 view
CYHB1950333 布洛芬片 ibuprofen Tablet Chemical Drugs Supplementary Application 2019-05-09 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2020-05-15 view
X0302194 三苯双脒 Tribendimidine Active ingredient Chemical Drugs(1.1) New Drug Application 2003-12-18 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2004-05-14 view
CXHL1401732 碳酸司维拉姆干混悬剂 sevelamer carbonate Suspension Chemical Drugs(3.1) New Drug Application 2015-03-11 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2016-02-29 view
CXL20022932 复方丁溴东莨菪碱片 Tablet Chemical Drugs(4) New Drug Application 2002-11-13 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2003-08-25 view
CXb20020157 美洛昔康 meloxicam Active ingredient Chemical Drugs(4) Supplementary Application 2002-03-18 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2002-07-17 view
CYHS0502040 甘油磷酸钠注射液 Sodium glycerophosphate Injection Chemical Drugs(6) Generic Drug 2005-04-12 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2005-11-23 view
CXHS0900139 盐酸苯氟雷司 benfluorex hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2009-11-30 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2011-01-05 view
CYHB2050699 克林霉素磷酸酯注射液 clindamycin phosphate Injection Chemical Drugs Supplementary Application 2020-11-13 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2021-10-11 view
Y0405683 磷酸川芎嗪注射液 ligustrazine phosphate Injection Chemical Drugs(6) Generic Drug 2004-07-29 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2005-02-25 view
CYHS1500911 贝那普利氢氯噻嗪片 benazepril hydrochloride;hydrochlorothiazide Tablet Chemical Drugs(6) Generic Drug 2016-05-23 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2016-11-09 view
X0304436 盐酸曲马多缓释片 tramadol hydrochloride Tablet, extended release Chemical Drugs Supplementary Application 2003-08-27 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2004-02-02 view
CYHS1301799 依达拉奉注射液 edaravone Injection Chemical Drugs(6) Generic Drug 2014-07-02 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited In Review 2014-06-30 view