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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL0501971 孟鲁司特钠分散片 montelukast sodium Tablet Chemical Drugs(5) New Drug Application 2005-11-10 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2006-07-04 view
CXHL0502565 孟鲁司特钠分散片 montelukast sodium Tablet Chemical Drugs(5) New Drug Application 2006-03-08 浙江康德药业集团有限公司 Zhejiang Kangde Pharmaceutical Group Co Ltd Certificate Issued 2007-11-01 view
CXHL0600508 孟鲁司特钠胶囊 montelukast sodium Capsule Chemical Drugs(5) New Drug Application 2006-06-02 太阳石(唐山)药业有限公司 Sunstone (Tangshan) Pharmaceutical Co Ltd Certificate Issued 2008-12-22 view
CXHL0600509 孟鲁司特钠散 montelukast sodium Powder Chemical Drugs(5) New Drug Application 2006-06-02 太阳石(唐山)药业有限公司 Sunstone (Tangshan) Pharmaceutical Co Ltd Certificate Issued 2008-11-05 view
CXHL0600686 孟鲁司特钠颗粒 montelukast sodium Granule Chemical Drugs(5) New Drug Application 2006-06-02 牡丹江恒远药业有限公司 Mudanjiang Hengyuan Pharmaceutical Co Ltd Certificate Issued 2008-10-23 view
CXHL1300085 孟鲁司特钠盐酸左西替利嗪胶囊 levocetirizine hydrochloride;montelukast sodium Capsule Chemical Drugs(3.2) New Drug Application 2013-07-18 北京韩美药品有限公司 Beijing Hanmi Pharmaceutical Co Ltd Certificate Issued 2015-12-15 view
CXHL1300984 孟鲁司特钠盐酸左西替利嗪颗粒 levocetirizine hydrochloride;montelukast sodium Granule Chemical Drugs(3.2) New Drug Application 2014-01-21 北京韩美药品有限公司 Beijing Hanmi Pharmaceutical Co Ltd Certificate Issued 2015-12-24 view
CXHL1301094 孟鲁司特钠口服冻干片 montelukast sodium Lyophilized Chemical Drugs(5) New Drug Application 2014-01-26 陕西量子高科药业有限公司 Shaanxi Quantum Hi Tech Pharmacy Co Ltd Certificate Issued 2015-12-24 view
CXHL1301095 孟鲁司特钠口服冻干片 montelukast sodium Lyophilized Chemical Drugs(5) New Drug Application 2014-01-26 陕西量子高科药业有限公司 Shaanxi Quantum Hi Tech Pharmacy Co Ltd Certificate Issued 2015-12-15 view
CXHL1301096 孟鲁司特钠口服冻干片 montelukast sodium Lyophilized Chemical Drugs(5) New Drug Application 2014-01-26 陕西量子高科药业有限公司 Shaanxi Quantum Hi Tech Pharmacy Co Ltd Certificate Issued 2015-12-15 view
CXHL1400182 孟鲁司特钠胶囊 montelukast sodium Capsule Chemical Drugs(5) New Drug Application 2014-06-25 天津汉瑞药业有限公司 Tianjin Hanrui Pharmaceutical Co Ltd Certificate Issued 2016-01-29 view
CXHL1400717 孟鲁司特钠盐酸左西替利嗪咀嚼片 levocetirizine hydrochloride;montelukast sodium Tablet Chemical Drugs(3.2) New Drug Application 2014-07-25 北京韩美药品有限公司 Beijing Hanmi Pharmaceutical Co Ltd Certificate Issued 2016-02-19 view
CXHL1502039 孟鲁司特钠口溶膜 montelukast sodium Film Chemical Drugs(5) New Drug Application 2016-01-28 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd Certificate Issued 2016-10-24 view
CXHL1502040 孟鲁司特钠口溶膜 montelukast sodium Film Chemical Drugs(5) New Drug Application 2016-01-28 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd Certificate Issued 2016-10-24 view
CXHL1502271 孟鲁司特钠口溶膜 montelukast sodium Film Chemical Drugs(5) New Drug Application 2016-04-05 上海现代制药股份有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2016-10-27 view
CXHL1502272 孟鲁司特钠口溶膜 montelukast sodium Film Chemical Drugs(5) New Drug Application 2016-04-05 上海现代制药股份有限公司 Shanghai Shyndec Pharmaceutical Co Ltd Certificate Issued 2016-10-27 view
CXHL2000554 孟鲁司特钠凝胶 montelukast sodium Gel Chemical Drugs(2.4;2.2) New Drug Application 2020-11-04 江阴贝瑞森制药有限公司 Jiangyin Beiruisen Pharmaceutical Co Ltd In Review 2020-11-03 view
CXHL2101853 孟鲁司特钠凝胶 montelukast sodium Gel Chemical Drugs(2.2) New Drug Application 2021-12-31 Jiangyin Beiruisen Pharmaceutical Co Ltd view
CXHL2101854 孟鲁司特钠凝胶 montelukast sodium Gel Chemical Drugs(2.2;2.4) New Drug Application 2021-12-31 Jiangyin Beiruisen Pharmaceutical Co Ltd view
CXHL2200839 孟鲁司特钠凝胶 montelukast sodium Gel Chemical Drugs(2.2;2.4) New Drug Application 2022-10-28 Aitia (Shanghai) Pharmaceutical Co Ltd view