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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0403201 盐酸左西替利嗪分散片 levocetirizine hydrochloride Tablet Chemical Drugs(5) New Drug Application 2004-06-16 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-01-17 view
X0403216 氨酚氯宗分散片 Chlorzoxazone;Paracetamol Tablet Chemical Drugs(5) New Drug Application 2004-06-16 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-02-08 view
Y0407251 注射用阿莫西林钠克拉维酸钾 amoxicillin sodium;potassium clavulanate Lyophilized Chemical Drugs(6) Generic Drug 2004-08-12 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-04-07 view
X0402545 布地奈德-R气雾剂 Aerosol Chemical Drugs(3.1) New Drug Application 2004-05-17 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-05-13 view
X0402544 布地奈德-R Active ingredient Chemical Drugs(3.1) New Drug Application 2004-05-17 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-05-13 view
X0405284 复方缬沙坦分散片 hydrochlorothiazide;valsartan Tablet Chemical Drugs(5) New Drug Application 2004-09-16 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-06-17 view
Y0401576 聚甲酚磺醛溶液 policresulen Topical solution Chemical Drugs(6) Generic Drug 2004-03-16 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-06-23 view
Y0413479 利鲁唑片 riluzole Tablet Chemical Drugs(6) Generic Drug 2004-11-08 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-07-15 view
X0406328 利鲁唑 riluzole Active ingredient Chemical Drugs(3.1) New Drug Application 2004-11-08 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-07-27 view
CXS01111 硝酸异山梨酯葡萄糖注射液 isosorbide dinitrate Injection Chemical Drugs(4) New Drug Application 2004-04-30 山东诚创医药技术开发有限公司山东鲁南贝特制药有限公司 Certificate Issued 2005-07-29 view
X0405366 缬沙坦分散片 valsartan Tablet Chemical Drugs(5) New Drug Application 2004-09-20 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-08-05 view
X0404269 非那雄胺片 finasteride Tablet Chemical Drugs New Drug Application 2004-08-01 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-08-10 view
X0404268 非那雄胺 finasteride Active ingredient Chemical Drugs New Drug Application 2004-08-01 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-08-10 view
CYHB0500545 单硝酸异山梨酯注射液 isosorbide mononitrate Injection Chemical Drugs Supplementary Application 2005-03-28 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-08-26 view
CYHB0500544 单硝酸异山梨酯注射液 isosorbide mononitrate Injection Chemical Drugs Supplementary Application 2005-03-28 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-08-26 view
X0408368 利鲁唑胶囊 riluzole Capsule Chemical Drugs(5) New Drug Application 2005-01-12 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-10-13 view
Y0401575 聚甲酚磺醛溶液 policresulen Topical solution Chemical Drugs(6) Generic Drug 2004-03-16 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2005-10-21 view
CYHB0502952 辛伐他汀片 Simvastatin Tablet Chemical Drugs Supplementary Application 2005-09-25 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2006-04-04 view
CYHB0502950 辛伐他汀片 Simvastatin Tablet Chemical Drugs Supplementary Application 2005-09-25 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2006-04-04 view
CXHS0501423 阿昔莫司分散片 acipimox Tablet Chemical Drugs(5) New Drug Application 2005-06-06 山东鲁南贝特制药有限公司 Lunan BETTER Pharmaceutical Co Ltd Certificate Issued 2006-04-04 view