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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
H20010268 孟鲁司特钠咀嚼片 montelukast sodium Tablet Chemical Drugs Import Drug Application 2001-11-19 默沙东(中国)有限公司 MSD R&D (China) Co Ltd Approval Completed-Pending Certificated 2002-12-05 view
H20010273 孟鲁司特钠片 montelukast sodium Tablet Chemical Drugs Import Drug Application 2001-11-19 默沙东(中国)有限公司 MSD R&D (China) Co Ltd Approval Completed-Pending Certificated 2002-12-05 view
CXL01H97 孟鲁司特钠 montelukast sodium Active ingredient Chemical Drugs(4) New Drug Application 2002-01-15 北京上地新世纪生物医药研究所 Beijing Shangdi Xinshiji Biological Medicine Research Institute Co Ltd Approval Completed-Pending Certificated 2003-03-06 view
CXL01H99 孟鲁司特钠咀嚼片 montelukast sodium Tablet Chemical Drugs(4) New Drug Application 2002-01-15 北京上地新世纪生物医药研究所 Beijing Shangdi Xinshiji Biological Medicine Research Institute Co Ltd Approval Completed-Pending Certificated 2003-03-06 view
CXL01H98 孟鲁司特钠片 montelukast sodium Tablet Chemical Drugs(4) New Drug Application 2002-01-15 北京上地新世纪生物医药研究所 Beijing Shangdi Xinshiji Biological Medicine Research Institute Co Ltd Approval Completed-Pending Certificated 2003-03-06 view
J0300058 孟鲁司特钠片 montelukast sodium Tablet Chemical Drugs Supplementary Application 2003-02-09 Merck Sharp&Dohme (Australia) Pty. Ltd. Merck Sharp & Dohme (Australia) Pty Ltd;MSD R&D (China) Co Ltd Approval Completed-Pending Certificated 2003-09-23 view
J0300226 孟鲁司特钠咀嚼片 montelukast sodium Tablet Chemical Drugs Supplementary Application 2003-03-11 默沙东(中国)有限公司 MSD R&D (China) Co Ltd Approval Completed-Pending Certificated 2003-06-12 view
J0300228 孟鲁司特钠片 montelukast sodium Tablet Chemical Drugs Supplementary Application 2003-03-11 Merck Sharp&Dohme (Australia) Pty. Ltd. Merck Sharp & Dohme (Australia) Pty Ltd;MSD R&D (China) Co Ltd Approval Completed-Pending Certificated 2003-06-12 view
J0300227 孟鲁司特钠咀嚼片 montelukast sodium Tablet Chemical Drugs Supplementary Application 2003-03-11 Merck Sharp & Dohme (Australia) Pty. Ltd. Merck Sharp & Dohme (Australia) Pty Ltd;MSD R&D (China) Co Ltd Approval Completed-Pending Certificated 2003-06-12 view
Y0300511 孟鲁司特钠片 montelukast sodium Tablet Chemical Drugs(6) Generic Drug 2003-11-06 鲁南制药股份有限公司 Lunan Pharmaceutical Group Corporation Certificate Issued 2004-01-14 view
Y0300510 孟鲁司特钠咀嚼片 montelukast sodium Tablet Chemical Drugs(6) Generic Drug 2003-11-06 鲁南制药股份有限公司 Lunan Pharmaceutical Group Corporation Certificate Issued 2004-01-14 view
X0300898 孟鲁司特钠 montelukast sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2003-11-06 鲁南制药股份有限公司 Lunan Pharmaceutical Group Corporation Certificate Issued 2004-03-19 view
J0400292 孟鲁司特钠口服颗粒 montelukast sodium Granule Chemical Drugs(3.1) Import Drug Application 2004-03-03 MSD R&D (China) Co Ltd Certificate Issued 2005-11-11 view
J0400427 孟鲁司特钠片 montelukast sodium Tablet Chemical Drugs Supplementary Application 2004-03-21 Merck Sharp&Dohme (Australia) Pty. Ltd. Merck Sharp & Dohme (Australia) Pty Ltd;MSD R&D (China) Co Ltd Certificate Issued 2004-08-30 view
J0400429 孟鲁司特钠咀嚼片 montelukast sodium Tablet Chemical Drugs Supplementary Application 2004-07-30 默沙东(中国)有限公司 MSD R&D (China) Co Ltd Certificate Issued 2005-01-17 view
J0400430 孟鲁司特钠咀嚼片 montelukast sodium Tablet Chemical Drugs Supplementary Application 2004-07-30 Merck Sharp & Dohme (Australia) Pty. Ltd. Merck Sharp & Dohme (Australia) Pty Ltd;MSD R&D (China) Co Ltd Certificate Issued 2005-01-17 view
CXHS0501025 孟鲁司特钠 montelukast sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2005-05-31 牡丹江恒远药业有限公司 Mudanjiang Hengyuan Pharmaceutical Co Ltd;Beijing Shangdi Xinshiji Biological Medicine Research Institute Co Ltd Certificate Issued 2006-04-19 view
CYHS0503025 孟鲁司特钠片 montelukast sodium Tablet Chemical Drugs(6) Generic Drug 2005-06-25 四川大冢制药有限公司 Sichuan Dazhong Pharmaceutical Co Ltd Certificate Issued 2006-04-19 view
CYHS0503024 孟鲁司特钠咀嚼片 montelukast sodium Tablet Chemical Drugs(6) Generic Drug 2005-06-25 四川大冢制药有限公司 Sichuan Dazhong Pharmaceutical Co Ltd Certificate Issued 2006-05-15 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