药品注册申请号：070221
申请类型：ANDA (仿制药申请)
申请人：PH HEALTH
申请人全名：PH HEALTH LTD
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 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG No No AB 1986/04/14 1986/04/14 Prescription
002 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG No No AB 1986/08/01 Prescription
003 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG No No AB 1986/08/01 Prescription
004 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG No No AB 1986/08/01 Prescription
005 PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 60MG No No AB 1986/09/24 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1986/04/14 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2012/01/27 SUPPL-23（补充） Approval Labeling-Package Insert
1991/11/13 SUPPL-19（补充） Approval Labeling
1991/02/13 SUPPL-18（补充） Approval Labeling
1989/10/02 SUPPL-21（补充） Approval Bioequivalence
1989/09/06 SUPPL-17（补充） Approval Labeling
1989/07/11 SUPPL-15（补充） Approval Labeling
1988/03/07 SUPPL-12（补充） Approval Manufacturing (CMC)
1988/02/11 SUPPL-3（补充） Approval Manufacturing (CMC)
1988/01/04 SUPPL-11（补充） Approval Manufacturing (CMC)
1988/01/04 SUPPL-10（补充） Approval Manufacturing (CMC)
1987/07/22 SUPPL-5（补充） Approval Manufacturing (CMC)
1987/07/22 SUPPL-4（补充） Approval Manufacturing (CMC)
1986/11/07 SUPPL-2（补充） Approval Manufacturing (CMC)
1986/11/07 SUPPL-1（补充） Approval Manufacturing (CMC)
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
无
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
无
与本品治疗等效的药品
>>>活性成分:PROPRANOLOL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:80MG; 治疗等效代码:AB<<<
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
070213 004 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 1985/11/19 MYLAN
070221 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 1986/04/14 PH HEALTH
070178 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 1986/05/13 WATSON LABS
070322 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 1986/08/04 INNOGENIX
071976 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No Yes AB 1988/04/06 IMPAX LABS INC
078213 005 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG Discontinued No No AB 2008/01/10 NORTHSTAR HLTHCARE
078955 005 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 80MG Prescription No No AB 2008/06/02 IPCA LABS LTD
>>>活性成分:PROPRANOLOL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:10MG; 治疗等效代码:AB<<<
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
070322 002 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1985/10/22 INNOGENIX
070213 002 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1985/11/19 MYLAN
070175 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1986/05/13 WATSON LABS
070221 002 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1986/08/01 PH HEALTH
071972 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 1988/04/06 IMPAX LABS INC
078213 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2008/01/10 NORTHSTAR HLTHCARE
078955 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2008/06/02 IPCA LABS LTD
>>>活性成分:PROPRANOLOL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:20MG; 治疗等效代码:AB<<<
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
070322 003 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 1985/10/22 INNOGENIX
070213 003 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 1985/11/19 MYLAN
070176 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 1986/05/13 WATSON LABS
070221 003 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 1986/08/01 PH HEALTH
071972 002 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 1988/04/06 IMPAX LABS INC
078213 002 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG Discontinued No No AB 2008/01/10 NORTHSTAR HLTHCARE
078955 002 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2008/06/02 IPCA LABS LTD
>>>活性成分:PROPRANOLOL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:40MG; 治疗等效代码:AB<<<
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
070219 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB -- VINTAGE PHARMS
070322 004 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 1985/10/22 INNOGENIX
070213 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 1985/11/19 MYLAN
070177 001 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 1986/05/13 WATSON LABS
070221 004 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 1986/08/01 PH HEALTH
071972 003 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 1988/04/06 IMPAX LABS INC
078213 003 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG Discontinued No No AB 2008/01/10 NORTHSTAR HLTHCARE
078955 003 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 40MG Prescription No No AB 2008/06/02 IPCA LABS LTD
>>>活性成分:PROPRANOLOL HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:60MG; 治疗等效代码:AB<<<
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
071976 002 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 1986/05/13 IMPAX LABS INC
070221 005 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 1986/09/24 PH HEALTH
070322 005 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 1986/09/24 INNOGENIX
078213 004 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 60MG Discontinued No No AB 2008/01/10 NORTHSTAR HLTHCARE
078955 004 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2008/06/02 IPCA LABS LTD
070213 005 ANDA PROPRANOLOL HYDROCHLORIDE PROPRANOLOL HYDROCHLORIDE TABLET;ORAL 60MG Prescription No No AB 2011/04/08 MYLAN
更多信息
药品NDC数据与药品包装、标签说明书
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