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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHS0700409 盐酸阿夫唑嗪分散片 alfuzosin hydrochloride Tablet Chemical Drugs(5) New Drug Application 2008-01-23 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2009-12-11 view
CYHS0506462 盐酸艾司洛尔注射液 esmolol hydrochloride Injection Chemical Drugs(6) Generic Drug 2005-10-13 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2008-11-12 view
CXHS1200332 甲磺酸伊马替尼 imatinib mesylate Active ingredient Chemical Drugs(3.1) New Drug Application 2013-02-20 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2015-12-24 view
CXSL1800032 重组人源化抗PD-1单克隆抗体注射液 Recombinant humanized anti-PD-1 monoclonal antibody Injection Biological Products(1) New Drug Application 2018-04-11 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2018-07-24 view
CXHR1100025 替吉奥分散片 gimeracil;Oteracil Patassium;tegafur Tablet Chemical Drugs State Standards 2011-04-15 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2011-12-06 view
CYHB0601330 盐酸艾司洛尔注射液 esmolol hydrochloride Injection Chemical Drugs Supplementary Application 2007-07-26 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2007-07-24 view
Y0414717 生长抑素 somatostatin Active ingredient Chemical Drugs(6) Generic Drug 2004-11-24 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2005-10-21 view
CXHL1200396 S-泮托拉唑钠 pantoprazole sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2012-08-24 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2015-10-29 view
CYHB1504040 注射用奥沙利铂 oxaliplatin Lyophilized Chemical Drugs Supplementary Application 2016-01-07 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2017-03-22 view
CYHB1001078 盐酸格拉司琼葡萄糖注射液 granisetron hydrochloride Injection Chemical Drugs Supplementary Application 2010-07-01 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2011-01-07 view
CXHS0600369 佐米曲普坦口腔崩解片 zolmitriptan Tablet Chemical Drugs(5) New Drug Application 2006-03-24 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2008-05-22 view
CYHS1302122 达沙替尼 dasatinib Active ingredient Chemical Drugs(6) Generic Drug 2014-10-31 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2014-10-29 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
CYHR0900076 盐酸表柔比星 epirubicin hydrochloride Active ingredient Chemical Drugs State Standards 2009-03-10 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2012-08-28 view
CXHL1500591 吉非替尼 gefitinib Active ingredient Chemical Drugs(3.1) New Drug Application 2015-06-19 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2016-07-14 view
CXHS0503045 七氟烷 sevoflurane Active ingredient Chemical Drugs New Drug Application 2005-12-27 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2008-11-05 view
CXHL0900452 琥珀酸美托洛尔 metoprolol succinate Active ingredient Chemical Drugs(3.1) New Drug Application 2009-11-30 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2010-09-06 view
CXHL1300893 阿齐沙坦片 azilsartan Tablet Chemical Drugs(3.1) New Drug Application 2013-10-28 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2016-01-21 view
CYHB2050712 注射用生长抑素 somatostatin Lyophilized Chemical Drugs Supplementary Application 2020-11-18 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Pending Approval 2021-12-20 view
CXHS1100264 噻托溴铵粉雾剂 tiotropium bromide Powder for inhalation Chemical Drugs(3.1) New Drug Application 2012-04-06 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2015-10-29 view