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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
X0300494 盐酸齐拉西酮 ziprasidone hydrochloride Active ingredient 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
X0302527 咪达唑仑注射液 midazolam Injection Chemical Drugs Supplementary Application 2003-05-28 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
X0302526 咪达唑仑注射液 midazolam Injection Chemical Drugs Supplementary Application 2003-05-28 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
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
Y0301708 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
X0304711 加巴喷丁胶囊 gabapentin Capsule Chemical Drugs(2) New Drug Application 2003-09-06 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2004-04-23 view
X0304710 加巴喷丁 gabapentin Active ingredient Chemical Drugs(2) New Drug Application 2003-09-06 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2004-04-23 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
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
Y0303594 大黄蛰虫胶囊 Capsule Chinese Herbal Medicine(11) Generic Drug 2003-10-10 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2004-06-11 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
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
X0302075 唑尼沙胺 zonisamide Active ingredient 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
Y0400015 阿奇霉素胶囊 azithromycin Capsule Chemical Drugs(6) Generic Drug 2004-01-08 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2004-07-21 view
Y0306012 罗红霉素胶囊 roxithromycin Capsule Chemical Drugs(6) Generic Drug 2004-01-08 徐州恩华药业集团有限责任公司 Jiangsu Nhwa Pharmaceutical Co Ltd Certificate Issued 2004-07-21 view