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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHL2400181 罗氟司特乳膏 roflumilast Cream Chemical Drugs(5.1) Import Drug Application 2024-07-20 Arcutis Biotherapeutics Inc view
JXHL2400172 罗氟司特乳膏 roflumilast Cream Chemical Drugs(2.4) Import Drug Application 2024-07-12 Arcutis Biotherapeutics Inc view
JXHL1000034 Roflumilast薄膜衣片 roflumilast Tablet Chemical Drugs Import Drug Application 2010-02-24 依格斯(北京)医疗科技有限公司 Excel Pharma Studies Inc Certificate Issued 2011-01-05 view
JXHL1200150 罗氟司特 roflumilast Active ingredient Chemical Drugs Import Drug Application 2012-05-28 德国奈科明有限公司北京代表处 Germany Wutian Co Ltd Beijing Representative Office Certificate Issued 2013-04-01 view
CXHL1100430 罗氟司特片 roflumilast Tablet Chemical Drugs(3.1) New Drug Application 2011-09-14 合肥立方制药股份有限公司 Hefei Lifeon Pharmaceutical Co Ltd Certificate Issued 2013-05-31 view
CXHL1100429 罗氟司特 roflumilast Active ingredient Chemical Drugs(3.1) New Drug Application 2011-09-14 合肥立方制药股份有限公司 Hefei Lifeon Pharmaceutical Co Ltd Certificate Issued 2013-05-31 view
JYHB1300645 罗氟司特片 roflumilast Tablet Chemical Drugs Supplementary Application 2013-06-06 北京法马苏提克咨询有限公司 Ppd Pharmaceutical Development (Beijing) Co Ltd Approval Completed-Pending Certificated 2014-07-21 view
CXHL1200301 罗氟司特 roflumilast Active ingredient Chemical Drugs(3.1) New Drug Application 2012-06-11 重庆华邦胜凯制药有限公司 Chongqing Huapont Shengchem Pharmaceutical Co Ltd Certificate Issued 2014-07-24 view
CXHL1200302 罗氟司特片 roflumilast Tablet Chemical Drugs(3.1) New Drug Application 2012-06-11 重庆华邦制药股份有限公司 Chongqing Huapont Pharmaceutical Co Ltd Certificate Issued 2014-07-24 view
JXHL1100435 罗氟司特片 roflumilast Tablet Chemical Drugs Import Drug Application 2011-12-15 北京法马苏提克咨询有限公司 Ppd Pharmaceutical Development (Beijing) Co Ltd Certificate Issued 2014-08-11 view
CXHL1200134 罗氟司特片 roflumilast Tablet Chemical Drugs(3.1) New Drug Application 2012-07-18 石家庄智恒医药科技有限公司 Hebei Zhiheng Pharmaceutical Co Ltd Certificate Issued 2014-10-10 view
CXHL1200132 罗氟司特 roflumilast Active ingredient Chemical Drugs(3.1) New Drug Application 2012-07-18 石家庄智恒医药科技有限公司 Hebei Zhiheng Pharmaceutical Co Ltd Certificate Issued 2014-10-10 view
CXHL1200416 罗氟司特 roflumilast Active ingredient Chemical Drugs(3.1) New Drug Application 2012-08-24 山东创新药物研发有限公司 Shandong Innovative Drug Research and Development Co Ltd Certificate Issued 2014-11-21 view
CXHL1200417 罗氟司特片 roflumilast Tablet Chemical Drugs(3.1) New Drug Application 2012-08-24 山东创新药物研发有限公司 Shandong Innovative Drug Research and Development Co Ltd Certificate Issued 2014-11-21 view
CXHL1100126 罗氟司特 roflumilast Active ingredient Chemical Drugs(3.1) New Drug Application 2011-04-22 天津市汉康医药生物技术有限公司 Tianjin Hankang Pharmaceutical & Biotechnology Company Limited Certificate Issued 2014-12-25 view
CXHL1100127 罗氟司特片 roflumilast Tablet Chemical Drugs(3.1) New Drug Application 2011-04-22 天津市汉康医药生物技术有限公司 Tianjin Hankang Pharmaceutical & Biotechnology Company Limited Certificate Issued 2014-12-25 view
CXHL1200410 罗氟司特 roflumilast Active ingredient Chemical Drugs(3.1) New Drug Application 2012-09-06 北京九洲济康医药有限责任公司 Hxss Pharmaceutical (Beijing) Co Ltd Certificate Issued 2015-03-26 view
CXHL1200411 罗氟司特片 roflumilast Tablet Chemical Drugs(3.1) New Drug Application 2012-09-06 北京九洲济康医药有限责任公司 Hxss Pharmaceutical (Beijing) Co Ltd Certificate Issued 2015-03-26 view
CXHL1100554 罗氟司特片 roflumilast Tablet Chemical Drugs(3.1) New Drug Application 2011-11-10 南京威斯特康生物技术有限公司 Nanjing Westcon Biotechnology Co Ltd Certificate Issued 2015-05-20 view
CXHL1100727 罗氟司特 roflumilast Active ingredient Chemical Drugs(3.1) New Drug Application 2012-01-13 江苏恒瑞医药股份有限公司 Jiangsu Hengrui Pharmaceuticals Co Ltd Certificate Issued 2015-05-20 view