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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
X0303671 注射用盐酸尼卡地平 nicardipine hydrochloride Lyophilized Chemical Drugs(5) New Drug Application 2003-08-06 吉林全威药业有限公司 Barrymore Pharmaceutical (Tonghua) Co Ltd Beijing Office Certificate Issued 2004-06-18 view
X0303673 注射用盐酸尼卡地平 nicardipine hydrochloride Lyophilized Chemical Drugs(5) New Drug Application 2003-08-06 吉林全威药业有限公司 Barrymore Pharmaceutical (Tonghua) Co Ltd Beijing Office Certificate Issued 2004-06-18 view
X0303672 注射用盐酸尼卡地平 nicardipine hydrochloride Lyophilized Chemical Drugs(5) New Drug Application 2003-08-06 吉林全威药业有限公司 Barrymore Pharmaceutical (Tonghua) Co Ltd Beijing Office Certificate Issued 2004-06-18 view
H20000288 盐酸尼卡地平 nicardipine hydrochloride Active ingredient Chemical Drugs Import Drug Application 2000-10-25 山之内制药株式会社北京事务所 Astellas Pharma Co Ltd Approval Completed-Pending Certificated 2001-10-25 view
JTH2200196 盐酸尼卡地平 nicardipine hydrochloride Active ingredient Chemical Drugs Disposable Import Drug Application 2022-09-21 Wockhardt Ltd;Guangdong Zorun Pharmaceutical Research and Develop Co Ltd view
CYHS1401346 盐酸尼卡地平 nicardipine hydrochloride Active ingredient Chemical Drugs(6) Generic Drug 2015-04-23 回音必集团抚州制药有限公司 Huiyinbi Group Fuzhou Pharmaceutical Co Ltd Certificate Issued 2017-08-14 view
JTH2200139 盐酸尼卡地平 nicardipine hydrochloride Active ingredient Chemical Drugs Disposable Import Drug Application 2022-07-20 Wockhardt Ltd;Anhui Pioneer Pharmaceutical Co Ltd view
JTH2200135 盐酸尼卡地平 nicardipine hydrochloride Active ingredient Chemical Drugs Disposable Import Drug Application 2022-07-14 Wockhardt Ltd;Guangdong Zorun Pharmaceutical Research and Develop Co Ltd view
CYHT1600454 盐酸尼卡地平 nicardipine hydrochloride Active ingredient Chemical Drugs Supplementary Application 2023-03-24 Jiangsu Cixing Pharmaceutical Co Ltd view
H20000287 盐酸尼卡地平 nicardipine hydrochloride Active ingredient Chemical Drugs Import Drug Application 2000-10-31 山之内制药株式会社北京事务所 Astellas Pharma Co Ltd Approval Completed-Pending Certificated 2001-10-25 view
X0408225 盐酸尼卡地平口崩片 nicardipine hydrochloride Tablet Chemical Drugs(5) New Drug Application 2005-01-05 江西万基药物研究院有限责任公司 Jiangxi Wanji Medicine Research Institute Pharmaceutical Co Ltd Certificate Issued 2005-07-29 view
JTH1900017 盐酸尼卡地平对照品 nicardipine hydrochloride Active ingredient Chemical Drugs Disposable Import Drug Application 2019-01-17 Eurofins Analytical Science Laboratories, Inc. Eurofins Analytical Science Laboratories Inc;Astellas Pharmaceutical (China) Co Ltd;Astellas Pharma Inc Certificate Issued 2019-02-12 view
X0300698 盐酸尼卡地平控释片 nicardipine hydrochloride Tablet, extended release Chemical Drugs(5) New Drug Application 2004-03-26 沈阳药科大学 Shenyang Pharmaceutical University;Jiangxi Feiyu Medical Technology Co Ltd Certificate Issued 2004-08-10 view
JTH1900153 盐酸尼卡地平有关物质L1对照品 Other Chemical Drugs Disposable Import Drug Application 2019-06-04 Eurofins Analytical Science Laboratories, Inc. Eurofins Analytical Science Laboratories Inc;Astellas Pharmaceutical (China) Co Ltd;Astellas Pharma Inc Certificate Issued 2019-07-15 view
JTH2100086 盐酸尼卡地平有关物质L1对照品 Other Chemical Drugs Disposable Import Drug Application 2021-04-06 Eurofins Analytical Science Laboratories, Inc. Eurofins Analytical Science Laboratories Inc;Ltl Pharma Co Ltd;Astellas Pharmaceutical (China) Co Ltd In Review 2021-04-01 view
CYHS0602083 盐酸尼卡地平氯化钠注射液 nicardipine hydrochloride Injection Chemical Drugs(6) Generic Drug 2006-05-22 山东鲁抗辰欣药业有限公司 Cisen Pharmaceutical Co Ltd Certificate Issued 2008-11-12 view
CYHS0604207 盐酸尼卡地平氯化钠注射液 nicardipine hydrochloride Injection Chemical Drugs(6) Generic Drug 2006-08-01 武汉市福星生物药业有限公司 Wuhan Fuxing BIO- Pharmaceutical Co Ltd Certificate Issued 2008-11-12 view
CYHS0602082 盐酸尼卡地平氯化钠注射液 nicardipine hydrochloride Injection Chemical Drugs(6) Generic Drug 2006-05-22 山东鲁抗辰欣药业有限公司 Cisen Pharmaceutical Co Ltd Certificate Issued 2008-11-05 view
CYHB2301271 盐酸尼卡地平氯化钠注射液 nicardipine hydrochloride Injection Chemical Drugs(原4) Supplementary Application 2023-06-02 Huiyinbi Group (Jiangxi) Dongya Pharmaceutical Co Ltd;Huiyinbi Group Fuzhou Pharmaceutical Co Ltd view
CYHB2401761 盐酸尼卡地平氯化钠注射液 nicardipine hydrochloride Injection Chemical Drugs(3) Supplementary Application 2024-10-31 Hainan Aike Pharmaceutical Co Ltd;Hainan Rukang Biotechnology Co Ltd view