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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
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
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
CYHB0502617 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
CYHB1850119 盐酸西替利嗪片 cetirizine hydrochloride Tablet Chemical Drugs Supplementary Application 2018-07-26 新华制药(高密)有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2019-08-13 view
CYHB1850338 盐酸地尔硫片 diltiazem hydrochloride Tablet Chemical Drugs Supplementary Application 2018-11-22 新华制药(高密)有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2020-09-23 view
CYHB2003730 盐酸西替利嗪片 cetirizine hydrochloride Tablet Chemical Drugs Supplementary Application 2020-05-29 新华制药(高密)有限公司 Xinhua Pharmaceutical (Gaomi) Co Ltd Certificate Issued 2020-08-17 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
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
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
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
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
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
X0303654 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
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