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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0407019 地红霉素肠溶胶囊 dirithromycin Capsule Chemical Drugs New Drug Application 2004-11-26 山东鲁抗辰欣药业有限公司 Cisen Pharmaceutical Co Ltd Certificate Issued 2005-08-26 view
X0407013 地红霉素肠溶片 dirithromycin Tablet Chemical Drugs New Drug Application 2004-11-26 西安利君制药股份有限公司 Xi'an Lijun Pharmaceutical Co Ltd Certificate Issued 2005-09-16 view
X0407012 地红霉素 dirithromycin Active ingredient Chemical Drugs New Drug Application 2004-11-26 西安利君制药股份有限公司 Xi'an Lijun Pharmaceutical Co Ltd Certificate Issued 2005-09-16 view
X0406738 地红霉素肠溶胶囊 dirithromycin Capsule Chemical Drugs(4) New Drug Application 2004-11-17 天津华津制药厂 Tianjin Huajin Pharmaceutcial Co Ltd Certificate Issued 2005-11-17 view
X0406737 地红霉素 dirithromycin Active ingredient Chemical Drugs New Drug Application 2004-11-17 河北冀衡(集团)药业有限公司 Hebei Jiheng Pharmaceutical Co Ltd Certificate Issued 2005-11-17 view
X0405582 地红霉素片 dirithromycin Tablet Chemical Drugs New Drug Application 2004-09-30 浙江金华康恩贝生物制药有限公司 Zhejiang Jinhua Conba BIO-PHARM Co Ltd Certificate Issued 2005-08-10 view
X0405581 地红霉素 dirithromycin Active ingredient Chemical Drugs New Drug Application 2004-09-30 浙江金华康恩贝生物制药有限公司 Zhejiang Jinhua Conba BIO-PHARM Co Ltd Certificate Issued 2005-08-10 view
X0404481 地红霉素肠溶微丸颗粒 dirithromycin Granule Chemical Drugs(5) New Drug Application 2004-08-12 哈尔滨圣吉药业有限公司 Harbin Shengji Pharmaceutical Co Ltd Certificate Issued 2005-04-04 view
X0404477 地红霉素肠溶胶囊 dirithromycin Capsule Chemical Drugs New Drug Application 2004-08-12 四川合信药业有限责任公司 Sichuan Hexin Pharmaceutical Co Ltd Certificate Issued 2005-02-23 view
X0404465 地红霉素肠溶微丸胶囊 dirithromycin Capsule Chemical Drugs(5) New Drug Application 2004-08-12 哈尔滨圣吉药业有限公司 Harbin Shengji Pharmaceutical Co Ltd Certificate Issued 2005-04-04 view
X0403918 地红霉素片 dirithromycin Tablet Chemical Drugs New Drug Application 2004-07-20 湖北丝宝药业有限公司 Hubei Shubang Pharmaceutical Co Ltd Filed view
X0403917 地红霉素 dirithromycin Active ingredient Chemical Drugs New Drug Application 2004-07-20 石家庄制药集团有限公司 Cspc Holdings Company Limited Certificate Issued 2005-06-29 view
X0401235 地红霉素肠溶颗粒 dirithromycin Granule Chemical Drugs(5) New Drug Application 2004-12-10 沈阳生物工程中心 Shenyang Biological Engineering Center Certificate Issued 2005-03-25 view
X0401140 地红霉素肠溶颗粒 dirithromycin Granule Chemical Drugs(5) New Drug Application 2005-01-07 山东益健药业有限公司 Shandong Yijian Pharmaceutical Co Ltd Certificate Issued 2005-04-30 view
X0305763 地红霉素肠溶胶囊 dirithromycin Capsule Chemical Drugs Supplementary Application 2003-11-07 山东淄博新达制药有限公司 Shandong Zibo Xinda Pharmaceutical Co Ltd Certificate Issued 2004-04-02 view
X0304992 地红霉素肠溶片 dirithromycin Tablet Chemical Drugs(3.1) New Drug Application 2004-09-03 昆山双鹤药业有限责任公司 Kunshan Double-Crane Pharmaceutical Co Ltd Certificate Issued 2005-02-23 view
X0304991 地红霉素 dirithromycin Active ingredient Chemical Drugs(4) New Drug Application 2004-09-03 昆山双鹤药业有限责任公司 Kunshan Double-Crane Pharmaceutical Co Ltd Certificate Issued 2005-02-23 view
CYHS1101810 地红霉素肠溶胶囊 dirithromycin Capsule Chemical Drugs(6) Generic Drug 2012-06-19 沈阳双鼎制药有限公司 Shenyang Shuangding Pharmaceutical Co Ltd Certificate Issued 2015-11-12 view
CYHS0800121 地红霉素肠溶片 dirithromycin Tablet Chemical Drugs(6) Generic Drug 2008-06-10 东北制药集团公司沈阳第一制药厂 NORTHEAST Pharmaceutical Group Shenyang NO1 Pharmaceutical Co Ltd Certificate Issued 2010-12-07 view
CYHB2101720 地红霉素肠溶片 dirithromycin Tablet Chemical Drugs Supplementary Application 2021-08-23 view