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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXS20020960 注射用盐酸索他洛尔 sotalol hydrochloride Lyophilized Chemical Drugs(4) New Drug Application 2003-11-04 哈尔滨康达药物研究所山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2004-12-24 view
X0306785 阿昔莫司缓释片 acipimox Tablet, extended release Chemical Drugs(5) New Drug Application 2003-12-25 临沂新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2004-08-09 view
X0306836 盐酸阿夫唑嗪分散片 alfuzosin hydrochloride Tablet Chemical Drugs(5) New Drug Application 2003-12-28 临沂新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-04-18 view
X0306835 去氧氟尿苷分散片 doxifluridine Tablet Chemical Drugs(5) New Drug Application 2003-12-28 临沂新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2004-07-05 view
Y0401577 聚甲酚磺醛栓 policresulen Suppository Chemical Drugs(6) Generic Drug 2004-03-16 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-06-23 view
X0402114 噻托溴铵粉雾剂 tiotropium bromide Powder for inhalation Chemical Drugs(3.1) New Drug Application 2004-04-21 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-06-23 view
X0402113 噻托溴铵 tiotropium bromide Active ingredient Chemical Drugs(3.1) New Drug Application 2004-04-21 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-06-23 view
X0402604 佐米曲普坦鼻喷雾剂 zolmitriptan Spray Chemical Drugs(3.3) New Drug Application 2004-05-17 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd;TEAM Academy of Pharmaceutical Sciences Certificate Issued 2005-08-31 view
X0402556 单硝酸异山梨酯滴丸 isosorbide mononitrate Pellet Chemical Drugs(5) New Drug Application 2004-05-17 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-05-12 view
X0402593 佐米曲普坦口腔崩解片 zolmitriptan Tablet Chemical Drugs(5) New Drug Application 2004-05-17 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd;TEAM Academy of Pharmaceutical Sciences Certificate Issued 2004-12-31 view
X0403232 阿那曲唑分散片 anastrozole Tablet Chemical Drugs(5) New Drug Application 2004-06-16 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-01-17 view
X0404304 枸橼酸莫沙必利滴丸 mosapride citrate Pellet Chemical Drugs(5) New Drug Application 2004-08-01 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-07-13 view
X0404264 佐米曲普坦 zolmitriptan Active ingredient Chemical Drugs New Drug Application 2004-08-01 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd;Lunan Pharmaceutical Group Corporation;TEAM Academy of Pharmaceutical Sciences Certificate Issued 2005-11-30 view
X0404265 佐米曲普坦片 zolmitriptan Tablet Chemical Drugs New Drug Application 2004-08-01 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd;Lunan Pharmaceutical Group Corporation;TEAM Academy of Pharmaceutical Sciences Certificate Issued 2005-11-30 view
Y0409506 苯磺酸左旋氨氯地平片 levamlodipine besylate Tablet Chemical Drugs(6) Generic Drug 2004-08-26 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-07-29 view
Y0409504 苯磺酸左旋氨氯地平 levamlodipine besylate Active ingredient Chemical Drugs(6) Generic Drug 2004-08-26 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-10-12 view
Y0409548 环孢素胶囊 ciclosporin Capsule Chemical Drugs(6) Generic Drug 2004-08-26 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-07-22 view
Y0409733 盐酸伐昔洛韦 valaciclovir hydrochloride Active ingredient Chemical Drugs(6) Generic Drug 2004-08-30 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-07-01 view
Y0410533 盐酸伐昔洛韦片 valaciclovir hydrochloride Tablet Chemical Drugs(6) Generic Drug 2004-09-16 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-06-29 view
X0405282 酒石酸唑吡坦分散片 zolpidem tartrate Tablet Chemical Drugs(5) New Drug Application 2004-09-16 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-04-01 view