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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0408519 注射用比阿培南 biapenem Lyophilized Chemical Drugs(3.1) New Drug Application 2005-01-12 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2007-04-13 view
X0408518 比阿培南 biapenem Active ingredient Chemical Drugs(3.1) New Drug Application 2005-01-12 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Approval Completed-Pending Certificated 2007-01-30 view
X0407363 复方缬沙坦分散片 hydrochlorothiazide;valsartan Tablet Chemical Drugs(3.2) New Drug Application 2004-12-09 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2006-01-16 view
X0407362 缬沙坦咀嚼片 valsartan Tablet Chemical Drugs(5) New Drug Application 2004-12-09 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2006-01-16 view
X0405620 氟特嗪胶囊 gimeracil;Oteracil Patassium;tegafur Capsule Chemical Drugs(3.2) New Drug Application 2004-10-09 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2005-05-20 view
X0405619 吉美嘧啶 gimeracil Active ingredient Chemical Drugs(3.1) New Drug Application 2004-10-10 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2005-05-27 view
X0405618 氧嗪酸钾 Oteracil Patassium Active ingredient Chemical Drugs(3.1) New Drug Application 2004-10-09 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2005-05-20 view
X0405502 美洛昔康注射液 meloxicam Injection Chemical Drugs(3.3) New Drug Application 2004-09-27 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2005-04-22 view
X0405172 富马酸阿奇霉素颗粒 Azithromycin Fumarate Granule Chemical Drugs(5) New Drug Application 2004-09-13 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2005-06-17 view
X0403934 米屈肼口服溶液 meldonium Oral solution Chemical Drugs(3.1) New Drug Application 2004-07-15 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2005-02-25 view
X0402066 伊曲康唑分散片 itraconazole Tablet Chemical Drugs(5) New Drug Application 2005-01-12 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2005-04-22 view
X0305943 甲钴胺 mecobalamin Active ingredient Chemical Drugs(4) New Drug Application 2003-11-13 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd;Welman (Xiang Bei) Pharmaceuticals Ltd Certificate Issued 2005-01-14 view
X0305840 盐酸吡格列酮胶囊 pioglitazone hydrochloride Capsule Chemical Drugs(1) New Drug Application 2004-06-11 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd;Shenyang Shide Pharmaceutical Co Ltd Certificate Issued 2004-12-24 view
X0305825 法罗培南钠颗粒 faropenem sodium Granule Chemical Drugs(3.1) New Drug Application 2004-07-19 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-10-15 view
X0305708 法罗培南钠片 faropenem sodium Tablet Chemical Drugs(3.1) New Drug Application 2003-11-07 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-06-04 view
X0305707 法罗培南钠胶囊 faropenem sodium Capsule Chemical Drugs(3.1) New Drug Application 2003-11-07 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-07-05 view
X0305706 法罗培南钠 faropenem sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2003-11-07 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-06-04 view
X0304142 左炔诺孕酮滴丸 levonorgestrel Pellet Chemical Drugs(5) New Drug Application 2004-04-28 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-08-16 view
X0301802 左亚叶酸钙注射液 calcium levofolinate Injection Chemical Drugs(3.1) New Drug Application 2003-04-08 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Issued 2004-02-02 view
X0301801 左羟丙哌嗪双层缓释片 levodropropizine Tablet, extended release Chemical Drugs(3.1) New Drug Application 2004-01-10 山东诚创医药技术开发有限公司 Shandong Chengchuang Pharmaceutical Technology Development Co Ltd Certificate Completed-Pending Issued 2004-06-15 view