药品注册申请号:065149
申请类型:ANDA (仿制药申请)
申请人:HQ SPECLT PHARMA
申请人全名:HQ SPECIALTY PHARMA CORP
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 1,000,000 UNITS/VIAL No No None 2009/07/23 2009/07/23 Prescription
002 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 5,000,000 UNITS/VIAL No No AP 2009/07/23 Prescription
003 PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 20,000,000 UNITS/VIAL No No AP 2009/07/23 Prescription
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2015/08/13 SUPPL-4(补充) Approval Labeling STANDARD
2012/09/04 SUPPL-2(补充) Approval Labeling
2009/07/23 ORIG-1(原始申请) Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
与本品治疗等效的药品
活性成分:PENICILLIN G POTASSIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:5,000,000 UNITS/VIAL 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
060657 002 ANDA PFIZERPEN PENICILLIN G POTASSIUM INJECTABLE;INJECTION 5,000,000 UNITS/VIAL Prescription No Yes AP Approved Prior to Jan 1, 1982 PFIZER
065079 002 ANDA PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 5,000,000 UNITS/VIAL Prescription No No AP 2002/08/30 SANDOZ
065149 002 ANDA PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 5,000,000 UNITS/VIAL Prescription No No AP 2009/07/23 HQ SPECLT PHARMA
065448 001 ANDA PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 5,000,000 UNITS/VIAL Prescription No No AP 2009/08/18 ISTITUTO BIO ITA SPA
205043 001 ANDA PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 5,000,000 UNITS/VIAL Prescription No No AP 2018/10/26 ACS DOBFAR SPA
活性成分:PENICILLIN G POTASSIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:20,000,000 UNITS/VIAL 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
060657 003 ANDA PFIZERPEN PENICILLIN G POTASSIUM INJECTABLE;INJECTION 20,000,000 UNITS/VIAL Prescription No Yes AP Approved Prior to Jan 1, 1982 PFIZER
065079 003 ANDA PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 20,000,000 UNITS/VIAL Prescription No No AP 2002/08/30 SANDOZ
065149 003 ANDA PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 20,000,000 UNITS/VIAL Prescription No No AP 2009/07/23 HQ SPECLT PHARMA
065448 002 ANDA PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 20,000,000 UNITS/VIAL Prescription No No AP 2009/08/18 ISTITUTO BIO ITA SPA
205043 002 ANDA PENICILLIN G POTASSIUM PENICILLIN G POTASSIUM INJECTABLE;INJECTION 20,000,000 UNITS/VIAL Prescription No No AP 2018/10/26 ACS DOBFAR SPA
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