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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXL01A47G 吡嘧司特钾 pemirolast potassium Active ingredient Chemical Drugs(2) New Drug Application 2001-12-06 南京第二制药厂 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2003-08-18 view
CXL20020498 水杨酸凝胶 salicylic acid Gel Chemical Drugs(4) New Drug Application 2002-03-18 南京第二制药厂 Nanjing Baijingyu Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2003-03-20 view
CXL01A48G 吡嘧司特钾片 pemirolast potassium Tablet Chemical Drugs(2) New Drug Application 2001-12-06 南京第二制药厂 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2003-08-18 view
CYHB1301403 硝苯地平片 nifedipine Tablet Chemical Drugs Supplementary Application 2013-10-11 南京白敬宇制药有限责公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2016-03-24 view
CYHS2000410 塞来昔布胶囊 celecoxib Capsule Chemical Drugs(4) Generic Drug 2020-06-20 南京白敬宇制药有限责任公司,福建海西新药创制有限公司 Nanjing Baijingyu Pharmaceutical Co Ltd;Fujian Haixi New Pharmaceutical Co Ltd Certificate Issued 2021-10-18 view
CYZB0602931 脱牙敏糊剂 Paste Chinese Herbal Medicine Supplementary Application 2006-11-30 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2007-08-23 view
Y0413180 吗替麦考酚酯 mycophenolate mofetil Active ingredient Chemical Drugs(6) Generic Drug 2004-11-09 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2005-12-06 view
CYHB2100101 复方甘草片 ANISE OIL;Sodium Benzoate;Camphor;Opium; Tablet Chemical Drugs(4) Supplementary Application 2021-01-16 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd In Review 2021-01-15 view
CYHB1203291 盐酸小檗碱片 berberine hydrochloride Tablet Chemical Drugs Supplementary Application 2013-04-02 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2016-07-21 view
CYHB0806882 阿司匹林肠溶片 Aspirin Tablet Chemical Drugs Supplementary Application 2008-08-29 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2009-01-16 view
CYHB0501282 氯霉素 chloramphenicol Active ingredient Chemical Drugs Supplementary Application 2005-05-17 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2006-01-20 view
CXHS1400065 扎托布洛芬 zaltoprofen Active ingredient Chemical Drugs(3.1) New Drug Application 2014-05-29 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd;Sichuan Dianhong Medicine Technology Development Company Certificate Issued 2016-10-11 view
CYHB0907794 酮康唑 ketoconazole Active ingredient Chemical Drugs Supplementary Application 2009-08-17 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2011-02-12 view
CXHB0600041 阿司匹林维生素C分散片 ascorbic acid;aspirin Tablet Chemical Drugs Supplementary Application 2006-02-07 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2007-05-15 view
X0400515 非那雄胺 finasteride Active ingredient Chemical Drugs New Drug Application 2004-02-06 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd;Huangshi Lishizhen Pharmaceutical Group Wuhan Lishizhen Pharmaceutical Co Ltd Certificate Issued 2004-12-24 view
CYHB1513128 复方α-酮酸片 D,L-Hydroxymethionine Calcium;D,L-α-Ketoisoleucine Calcium;histidine;Lysine acetate;threonine;tryptophan;tyrosine;α-Ketoleucine Calcium;α-Ketophenylalanine Calcium;α-Ketovaline Calcium Tablet Chemical Drugs Supplementary Application 2016-06-30 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2017-03-22 view
CXHS0900266 盐酸沙格雷酯 sarpogrelate hydrochloride Active ingredient Chemical Drugs(3.1) New Drug Application 2011-01-10 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd;Technology Center of Jinling Pharmaceutical Co Ltd;Nanjing Kangran Medicine Technology Co Ltd Certificate Issued 2013-08-09 view
CYHS0700132 联苯苄唑乳膏 bifonazole Cream Chemical Drugs(6) Generic Drug 2007-04-26 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2008-09-03 view
CYHB0501280 次硝酸铋 Bismuth Subnitnate Active ingredient Chemical Drugs Supplementary Application 2005-05-17 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd Certificate Issued 2005-08-25 view
CXHS1300147 度他雄胺 dutasteride Active ingredient Chemical Drugs(3.1) New Drug Application 2013-11-21 南京白敬宇制药有限责任公司 Nanjing Baijingyu Pharmaceutical Co Ltd;Nanjing Lifenergy R&D Co Ltd;Dihon Pharmaceutical Group Co Ltd Certificate Issued 2016-01-22 view