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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL0500264 利培酮分散片 risperidone Tablet Chemical Drugs(5) New Drug Application 2005-02-24 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2005-10-08 view
CXHL0501526 盐酸丁螺环酮口腔崩解片 buspirone hydrochloride Tablet Chemical Drugs(5) New Drug Application 2005-08-17 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-06-28 view
CXHL0501752 盐酸度洛西汀 duloxetine hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2005-10-13 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-06-28 view
CXHL0501753 盐酸度洛西汀肠溶片 duloxetine hydrochloride Tablet Chemical Drugs(3.1) New Drug Application 2005-10-16 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-06-28 view
CXHL0502040 普瑞巴林 pregabalin Active ingredient Chemical Drugs(3.1) New Drug Application 2005-11-20 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-08-17 view
CXHL0502041 普瑞巴林胶囊 pregabalin Capsule Chemical Drugs(3.1) New Drug Application 2005-11-20 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-08-17 view
CXHL0502586 氯氮平口腔崩解片 clozapine Tablet Chemical Drugs(5) New Drug Application 2006-03-02 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-11-06 view
CXHS0500485 尼扎替丁片 nizatidine Tablet Chemical Drugs(5) New Drug Application 2005-03-28 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-04-04 view
CXHS0501037 甲磺酸罗哌卡因 ropivacaine mesylate Active ingredient Chemical Drugs New Drug Application 2005-05-12 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-01-12 view
CXHS0501038 甲磺酸罗哌卡因注射液 ropivacaine mesylate Injection Chemical Drugs New Drug Application 2005-05-12 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-01-12 view
CXHS0502205 盐酸齐拉西酮 ziprasidone hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2005-10-13 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-07-10 view
CXHS0502206 盐酸齐拉西酮胶囊 ziprasidone hydrochloride Capsule Chemical Drugs(3.1) New Drug Application 2005-10-13 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-07-10 view
CXHS0502491 氨酚匹林咖啡因片 aspirin;caffeine;paracetamol Tablet Chemical Drugs New Drug Application 2005-11-15 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2007-06-01 view
CXHS0600020 大豆磷脂 Soya Lecithin Active ingredient Chemical Drugs(3.1) New Drug Application 2006-03-01 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2009-04-27 view
CXL20020731G 阿酚咖片 aspirin;caffeine;paracetamol Tablet Chemical Drugs(4) New Drug Application 2002-06-03 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2003-04-21 view
CXL20022139 利鲁唑 riluzole Active ingredient Chemical Drugs(4) New Drug Application 2002-09-02 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2003-11-03 view
CXL20022140 利鲁唑片 riluzole Tablet Chemical Drugs(4) New Drug Application 2002-09-02 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2003-11-03 view
CXL20022289G 甲磺酸罗哌卡因 ropivacaine mesylate Active ingredient Chemical Drugs(4) New Drug Application 2003-11-11 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2004-04-09 view
CXL20022290G 甲磺酸罗哌卡因注射液 ropivacaine mesylate Injection Chemical Drugs(4) New Drug Application 2003-11-11 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2004-04-09 view
CYHS0500712 阿奇霉素胶囊 azithromycin Capsule Chemical Drugs(6) Generic Drug 2005-02-26 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2005-10-09 view