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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHS2300098 注射用左奥拉西坦 Lyophilized Chemical Drugs(2.1) New Drug Application 2023-11-09 Shenghe (China) Biopharmaceutical Co Ltd;Nanjing Bode Biopharmaceutical Co Ltd view
CYHB2300008 奥拉西坦葡萄糖注射液 oxiracetam Injection Chemical Drugs(原3.3) Supplementary Application 2023-01-04 Harbin Medisan Pharmaceutical Co Ltd view
CYHB2300009 奥拉西坦氯化钠注射液 oxiracetam Injection Chemical Drugs(原3.3) Supplementary Application 2023-01-04 Harbin Medisan Pharmaceutical Co Ltd view
CYHB2201024 奥拉西坦注射液 oxiracetam Injection Chemical Drugs(原6) Supplementary Application 2022-06-23 Ma'anshan Fengyuan Pharmaceutical Co Ltd;Anhui Xinshiji Pharmaceutical Co Ltd view
CYHB2101921 奥拉西坦注射液 oxiracetam Injection Chemical Drugs Supplementary Application 2021-09-29 Guangdong Shixin Pharmaceutical Co Ltd view
CYHB2100264 奥拉西坦注射液 oxiracetam Injection Chemical Drugs Supplementary Application 2021-02-24 朗天药业(湖北)有限公司 Lodays Pharmaceutical(Hubei) Co Ltd Certificate Issued 2021-11-15 view
CYHB2000616 奥拉西坦注射液 oxiracetam Injection Chemical Drugs Supplementary Application 2020-02-18 广东世信药业有限公司 Guangdong Shixin Pharmaceutical Co Ltd Certificate Issued 2020-12-21 view
CYHB1906818 奥拉西坦注射液 oxiracetam Injection Chemical Drugs Supplementary Application 2019-12-05 哈尔滨三联药业股份有限公司 Harbin Medisan Pharmaceutical Co Ltd Certificate Issued 2020-07-23 view
CYHR1900004 奥拉西坦注射液 oxiracetam Injection Chemical Drugs State Standards 2019-05-27 天津药物研究院药业有限责任公司 Tipr Pharmaceutical Co Ltd Certificate Issued 2020-02-12 view
CYHR1900003 奥拉西坦注射液 oxiracetam Injection Chemical Drugs State Standards 2019-05-27 天津药物研究院药业有限责任公司 Tipr Pharmaceutical Co Ltd Certificate Issued 2020-02-12 view
CYHB1902608 奥拉西坦胶囊 oxiracetam Capsule Chemical Drugs Supplementary Application 2019-05-16 湖南健朗药业有限责任公司 Hunan Jianlang Pharmaceutical Industry Co Ltd Certificate Issued 2019-08-06 view
CYHB1902163 奥拉西坦注射液 oxiracetam Injection Chemical Drugs Supplementary Application 2019-04-29 哈尔滨三联药业股份有限公司 Harbin Medisan Pharmaceutical Co Ltd Certificate Issued 2019-07-24 view
CYHB1901204 奥拉西坦注射液 oxiracetam Injection Chemical Drugs Supplementary Application 2019-03-25 哈尔滨三联药业股份有限公司 Harbin Medisan Pharmaceutical Co Ltd Certificate Issued 2020-05-08 view
CXHR1900004 奥拉西坦氯化钠注射液 oxiracetam Injection Chemical Drugs State Standards 2019-03-08 吉林四长制药有限公司 Jilin Sichang Pharmaceutical Co Ltd Certificate Issued 2021-09-14 view
CXHR1900003 奥拉西坦葡萄糖注射液 oxiracetam Injection Chemical Drugs State Standards 2019-03-04 吉林四长制药有限公司 Jilin Sichang Pharmaceutical Co Ltd Certificate Issued 2021-09-14 view
CYHB1803873 奥拉西坦注射液 oxiracetam Injection Chemical Drugs Supplementary Application 2018-08-29 山西优胜美特药业有限公司 Shanxi Puheng Pharmaceutical Co Ltd Certificate Issued 2021-01-27 view
CYHS1700619 奥拉西坦注射液 oxiracetam Injection Chemical Drugs(4) Generic Drug 2018-06-22 天津药物研究院药业有限责任公司 Tipr Pharmaceutical Co Ltd Certificate Issued 2019-03-14 view
CYHS1700620 奥拉西坦注射液 oxiracetam Injection Chemical Drugs(4) Generic Drug 2018-06-22 天津药物研究院药业有限责任公司 Tipr Pharmaceutical Co Ltd Certificate Issued 2019-03-14 view
CYHS1700264 奥拉西坦片 oxiracetam Tablet Chemical Drugs(3) Generic Drug 2018-02-09 华北制药股份有限公司 North China Pharmaceutical CompanyLtd;Hebei Chuangjian Pharmaceutical Co Ltd Certificate Issued 2020-04-27 view
CYHB1707714 奥拉西坦 oxiracetam Active ingredient Chemical Drugs Supplementary Application 2017-12-18 江苏诚信药业有限公司 Jiangsu Chengxin Pharmaceutical Co Ltd In Review 2017-12-14 view