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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0402658 达依泊汀α注射液 darbepoetin alfa Injection Biological Products(7) New Drug Application 2004-05-24 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2005-02-25 view
X0402659 达依泊汀α注射液 darbepoetin alfa Injection Biological Products(7) New Drug Application 2004-05-24 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2005-02-25 view
CXSB0500112 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Supplementary Application 2005-11-20 麒麟鲲鹏(中国)生物药业有限公司 Kyowa Hakko Kirin China Pharmaceutical Co Ltd Certificate Issued 2006-05-29 view
JXSL0900058 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2009-08-11 安进有限公司 Amgen Inc Certificate Issued 2011-08-04 view
JXSL0900059 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2009-08-11 安进有限公司 Amgen Inc Certificate Issued 2011-08-04 view
JXSL0900060 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2009-08-11 安进有限公司 Amgen Inc Certificate Issued 2011-08-04 view
JXSL0900057 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2009-08-14 安进有限公司 Amgen Inc Certificate Issued 2011-08-04 view
JXSL1000052 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2010-11-29 协和发酵麒麟株式会社 Kyowa Hakko Kirin Co Ltd Certificate Issued 2013-01-08 view
JXSL1000051 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2010-11-29 协和发酵麒麟株式会社 Kyowa Hakko Kirin Co Ltd Certificate Issued 2013-01-08 view
JXSL1000050 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2010-11-29 协和发酵麒麟株式会社 Kyowa Hakko Kirin Co Ltd Certificate Issued 2013-01-08 view
JXSL1000055 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2010-11-29 协和发酵麒麟株式会社 Kyowa Hakko Kirin Co Ltd Certificate Issued 2013-01-08 view
JXSL1000054 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2010-11-29 协和发酵麒麟株式会社 Kyowa Hakko Kirin Co Ltd Certificate Issued 2013-01-08 view
JXSL1000053 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2010-11-29 协和发酵麒麟株式会社 Kyowa Hakko Kirin Co Ltd Certificate Issued 2013-01-08 view
JXSL1100019 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2011-03-29 安进有限公司 Amgen Inc Certificate Issued 2013-07-30 view
JXSL1100017 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2011-03-29 安进有限公司 Amgen Inc Certificate Issued 2013-07-30 view
JXSL1100018 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2011-03-29 安进有限公司 Amgen Inc Certificate Issued 2013-07-30 view
JXSL1100016 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2011-04-01 安进有限公司 Amgen Inc Certificate Issued 2013-07-30 view
JXSS1500005 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2015-04-10 协和发酵麒麟株式会社 Kyowa Hakko Kirin Co Ltd Certificate Issued 2016-04-12 view
JXSS1500004 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2015-04-10 协和发酵麒麟株式会社 Kyowa Hakko Kirin Co Ltd Certificate Issued 2016-04-12 view
JXSS1500003 达依泊汀α注射液 darbepoetin alfa Injection Biological Products Import Drug Application 2015-04-10 协和发酵麒麟株式会社 Kyowa Hakko Kirin Co Ltd Certificate Issued 2016-04-12 view