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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL2200800 OAB-14干混悬剂 Suspension Chemical Drugs(1) New Drug Application 2022-10-18 Shandong Xinhua Pharmaceutical Company Limited view
CXHL2200799 OAB-14干混悬剂 Suspension Chemical Drugs(1) New Drug Application 2022-10-18 Shandong Xinhua Pharmaceutical Company Limited 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
X0407551 三苯双脒肠溶片 Tribendimidine Tablet Chemical Drugs Supplementary Application 2004-12-16 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2005-12-14 view
X0407550 三苯双脒肠溶片 Tribendimidine Tablet Chemical Drugs Supplementary Application 2004-12-16 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2005-12-14 view
X0302197 三苯双脒肠溶片 Tribendimidine Tablet 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 2004-09-10 view
X0302196 三苯双脒肠溶片 Tribendimidine Tablet 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
X0407549 三苯双脒肠溶片 Tribendimidine Tablet Chemical Drugs Supplementary Application 2004-12-16 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2005-12-14 view
X0302195 三苯双脒肠溶片 Tribendimidine Tablet 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
CXL00540 丙戊茶碱 propentofylline Active ingredient Chemical Drugs(2) New Drug Application 2001-08-10 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2004-10-10 view
CXL00541 丙戊茶碱片 propentofylline Tablet Chemical Drugs(2) New Drug Application 2001-08-10 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2004-10-10 view
CYHB0503721 乙酰螺旋霉素片 Acetylspiramycin Tablet Chemical Drugs Supplementary Application 2006-03-24 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Completed-Pending Issued 2006-11-14 view
CYHB0503720 乙酰螺旋霉素片 Acetylspiramycin Tablet Chemical Drugs Supplementary Application 2006-03-24 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2006-11-23 view
CYHS2303097 二十碳五烯酸乙酯软胶囊 icosapent ethyl Soft capsules Chemical Drugs(4) Generic Drug 2023-11-11 Shandong Xinhua Pharmaceutical Company Limited view
CYHS2303096 二十碳五烯酸乙酯软胶囊 icosapent ethyl Soft capsules Chemical Drugs(4) Generic Drug 2023-11-11 Shandong Xinhua Pharmaceutical Company Limited view
CYHS1302041 伏格列波糖片 voglibose Tablet Chemical Drugs(6) Generic Drug 2014-09-17 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited In Review 2014-09-16 view
CXL01525 依诺沙星凝胶 enoxacin Gel Chemical Drugs(4) New Drug Application 2001-07-27 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2003-04-18 view
Y0304395 依诺沙星片 enoxacin Tablet Chemical Drugs Supplementary Application 2003-11-05 山东新华制药股份有限公司 Shandong Xinhua Pharmaceutical Company Limited Certificate Issued 2004-03-19 view
CYHS1301797 依达拉奉 edaravone Active ingredient 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
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