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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0402209 利培酮 risperidone Active ingredient Chemical Drugs New Drug Application 2004-04-26 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2005-01-31 view
X0300495 盐酸齐拉西酮胶囊 ziprasidone hydrochloride Capsule Chemical Drugs(3.1) New Drug Application 2003-02-09 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2003-11-14 view
CYHS0505304 西洛他唑 cilostazol Active ingredient Chemical Drugs(6) Generic Drug 2005-07-10 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2006-03-08 view
Y0410516 非诺贝特微粒化胶囊 fenofibrate Capsule Chemical Drugs(6) Generic Drug 2004-09-16 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2005-02-25 view
X0300201 西洛他唑 cilostazol Active ingredient Chemical Drugs(3.1) New Drug Application 2003-09-09 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2003-12-26 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
Y0416847 盐酸纳洛酮注射液 naloxone hydrochloride Injection Chemical Drugs(6) Generic Drug 2005-01-05 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2005-10-18 view
X0400038 阿立哌唑 aripiprazole Active ingredient Chemical Drugs(3.1) New Drug Application 2004-01-10 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2004-07-29 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
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
X0403963 加巴喷丁胶囊 gabapentin Capsule Chemical Drugs Supplementary Application 2004-07-20 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2004-11-01 view
Y0301709 氟康唑胶囊 fluconazole Capsule Chemical Drugs(6) Generic Drug 2003-06-12 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2003-12-30 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
X0407175 加巴喷丁胶囊 gabapentin Capsule Chemical Drugs Supplementary Application 2004-12-02 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2005-06-22 view
X0302076 唑尼沙胺胶囊 zonisamide Capsule Chemical Drugs(3.1) New Drug Application 2003-11-12 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2004-03-12 view
CYHS0690062 非诺贝特微粒化胶囊 fenofibrate Capsule Chemical Drugs(6) Generic Drug 2006-02-28 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2008-05-22 view
CYHS0500726 罗红霉素胶囊 roxithromycin 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 2005-10-12 view
CYHS0502869 酮康唑 ketoconazole Active ingredient Chemical Drugs(6) Generic Drug 2005-05-12 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2005-12-06 view
Y0410447 盐酸氯米帕明注射液 clomipramine hydrochloride Injection Chemical Drugs(6) Generic Drug 2004-09-16 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2005-06-23 view
Y0300097 西洛他唑片 cilostazol Tablet Chemical Drugs(6) Generic Drug 2003-09-09 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2003-12-29 view