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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYHB2400208 盐酸胺碘酮注射液 amiodarone hydrochloride Injection Chemical Drugs(4) Supplementary Application 2024-02-05 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd view
CYHB2350095 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs Supplementary Application 2023-01-30 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd view
CYHB2350096 注射用奥美拉唑钠 Omeprazole Sodium Lyophilized Chemical Drugs Supplementary Application 2023-01-30 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd view
CXB20020507 注射用蛇毒血凝酶 Lyophilized Chemical Drugs Supplementary Application 2002-08-13 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2003-05-30 view
CXB20020506 蛇毒血凝酶 Active ingredient Chemical Drugs Supplementary Application 2002-08-13 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2003-05-30 view
X0303819 谷维素注射液 oryzanol Injection Chemical Drugs Supplementary Application 2003-08-06 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2003-12-29 view
Y0301467 藻酸双酯钠注射液 Alginidatum Natricum Injection Chemical Drugs(6) Generic Drug 2003-05-28 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2004-01-17 view
X0302560 注射用藻酸双酯钠 Alginidatum Natricum Lyophilized Chemical Drugs(5) New Drug Application 2003-05-28 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2004-02-13 view
X0303610 注射用克林霉素磷酸酯 clindamycin phosphate Lyophilized Chemical Drugs Supplementary Application 2003-08-06 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2004-03-19 view
X0306851 注射用谷氨酸诺氟沙星 Norfloxacin Glutamate Lyophilized Chemical Drugs(5) New Drug Application 2003-12-28 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2004-08-09 view
Y0303982 更昔洛韦 ganciclovir Active ingredient Chemical Drugs(6) Generic Drug 2004-06-07 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2004-09-16 view
X0305333 注射用重酒石酸长春瑞滨 Vinorelbine Bitartrate Lyophilized Chemical Drugs(5) New Drug Application 2004-04-23 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2004-09-20 view
Y0303981 注射用更昔洛韦 ganciclovir Lyophilized Chemical Drugs(6) Generic Drug 2004-06-07 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2004-09-24 view
X0305806 注射用曲克芦丁 troxerutin Lyophilized Chemical Drugs(5) New Drug Application 2004-07-06 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2004-12-15 view
X0402323 谷维素软胶囊 oryzanol Soft capsules Chemical Drugs(5) New Drug Application 2004-05-08 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2004-12-31 view
X0402116 注射用环磷腺苷葡胺 MegIumine Adenosine Cyelophosphate Lyophilized Chemical Drugs(5) New Drug Application 2004-04-21 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2005-02-04 view
X0402117 注射用环磷腺苷葡胺 MegIumine Adenosine Cyelophosphate Lyophilized Chemical Drugs(5) New Drug Application 2004-04-21 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2005-02-04 view
X0401030 注射用氨甲苯酸 Aminomethylbenzoic acid Lyophilized Chemical Drugs(5) New Drug Application 2004-09-23 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2005-02-21 view
X0401156 草酸艾西酞普兰片 escitalopram oxalate Tablet Chemical Drugs(3.1) New Drug Application 2004-12-16 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2005-03-21 view
X0401155 草酸艾西酞普兰 escitalopram oxalate Active ingredient Chemical Drugs(3.1) New Drug Application 2004-12-16 山东北大高科华泰制药有限公司 Shandong Pku high-tech Huatai Pharmaceutical Co Ltd Certificate Issued 2005-03-21 view