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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHB2250278 克拉霉素颗粒 clarithromycin Granule Chemical Drugs Supplementary Application 2022-05-11 Xinhua Pharmaceutical (Gaomi) Co Ltd view
CYHB2400224 克拉霉素颗粒 clarithromycin Granule Chemical Drugs Supplementary Application 2024-02-06 Xinhua Pharmaceutical (Gaomi) Co Ltd view
CYHB0501483 注射用阿洛西林钠 azlocillin sodium Lyophilized Chemical Drugs Supplementary Application 2005-12-27 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2006-05-23 view
CXS01504 注射用阿奇霉素 azithromycin Lyophilized Chemical Drugs(4) New Drug Application 2001-12-14 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2003-04-02 view
Y0405060 注射用阿洛西林钠 azlocillin sodium Lyophilized Chemical Drugs(6) Generic Drug 2004-07-15 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2005-02-08 view
CYHB0502616 注射用美洛西林钠 Mezlocillin sodium Lyophilized Chemical Drugs Supplementary Application 2005-11-10 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2006-04-04 view
X0303653 注射用美洛西林钠 Mezlocillin sodium Lyophilized Chemical Drugs Supplementary Application 2003-08-06 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2004-04-02 view
Y0305330 注射用哌拉西林钠 piperacillin sodium Lyophilized Chemical Drugs(6) Generic Drug 2004-07-21 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2005-01-28 view
Y0405059 注射用阿洛西林钠 azlocillin sodium Lyophilized Chemical Drugs(6) Generic Drug 2004-07-15 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2005-02-08 view
CYHS0502289 注射用替卡西林钠克拉维酸钾 potassium clavulanate;ticarcillin sodium Lyophilized Chemical Drugs(6) Generic Drug 2005-04-21 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2005-12-30 view
X0300562 阿奇霉素分散片 azithromycin Tablet Chemical Drugs Supplementary Application 2003-02-09 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2003-05-16 view
Y0305329 注射用氨苄西林钠舒巴坦钠 ampicillin sodium;sulbactam sodium Lyophilized Chemical Drugs(6) Generic Drug 2004-07-21 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2005-02-04 view
CYHB0501491 注射用阿洛西林钠 azlocillin sodium Lyophilized Chemical Drugs Supplementary Application 2005-12-27 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Completed-Pending Issued 2006-05-16 view
CXHS0500893 替卡西林钠 ticarcillin sodium Active ingredient Chemical Drugs(3.1) New Drug Application 2005-04-21 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2006-01-12 view
X0300563 阿奇霉素分散片 azithromycin Tablet Chemical Drugs Supplementary Application 2003-02-09 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Approval Completed-Pending Certificated 2003-06-04 view
Y0405058 阿洛西林钠 azlocillin sodium Active ingredient Chemical Drugs(6) Generic Drug 2004-07-15 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2004-12-06 view
CYHB0501490 注射用阿洛西林钠 azlocillin sodium Lyophilized Chemical Drugs Supplementary Application 2005-12-27 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2006-05-23 view
X0300561 罗红霉素干混悬剂 roxithromycin Suspension Chemical Drugs Supplementary Application 2004-01-12 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2004-04-02 view
CXS01503 注射用阿奇霉素 azithromycin Lyophilized Chemical Drugs(4) New Drug Application 2001-12-14 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2003-04-02 view
Y0405061 注射用阿洛西林钠 azlocillin sodium Lyophilized Chemical Drugs(6) Generic Drug 2004-07-15 山东天达生物制药股份有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2005-02-08 view