药品注册申请号:072637
申请类型:ANDA (仿制药申请)
申请人:SUN PHARM INDUSTRIES
申请人全名:SUN PHARMACEUTICAL INDUSTRIES INC
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 ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 4MG BASE No No AB 1989/02/01 1989/12/05 Prescription
002 ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 2MG BASE No No AB 1989/12/05 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2002/12/11 SUPPL 17 Approval Manufacturing (CMC)
2002/07/03 SUPPL 16 Approval Manufacturing (CMC)
2002/05/01 SUPPL 14 Approval Manufacturing (CMC)
2002/03/04 SUPPL 15 Approval Manufacturing (CMC)
2000/05/16 SUPPL 13 Approval Manufacturing (CMC)
2000/05/16 SUPPL 12 Approval Manufacturing (CMC)
1998/06/12 SUPPL 11 Approval Labeling
1997/12/05 SUPPL 10 Approval Manufacturing (CMC)
1997/02/24 SUPPL 9 Approval Manufacturing (CMC)
1995/06/22 SUPPL 8 Approval Manufacturing (CMC)
1994/01/12 SUPPL 7 Approval Manufacturing (CMC)
1993/10/25 SUPPL 6 Approval Manufacturing (CMC)
1993/02/09 SUPPL 5 Approval Labeling
1992/11/05 SUPPL 4 Approval Labeling
1991/02/04 SUPPL 3 Approval Labeling
1990/08/29 SUPPL 2 Approval Labeling
1989/03/22 SUPPL 1 Approval Labeling
1989/02/01 ORIG 1 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:ALBUTEROL SULFATE 剂型/给药途径:TABLET;ORAL 规格:EQ 4MG BASE 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
072637 001 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 1989/12/05 SUN PHARM INDUSTRIES
072894 001 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 4MG BASE Prescription No Yes AB 1991/01/17 MYLAN
208804 002 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2018/05/21 AMNEAL PHARMS CO
207046 002 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2018/06/29 APPCO PHARMA LLC
211397 002 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2018/10/26 VIRTUS PHARM
210948 002 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 4MG BASE Prescription No No AB 2019/03/15 ARISE
活性成分:ALBUTEROL SULFATE 剂型/给药途径:TABLET;ORAL 规格:EQ 2MG BASE 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
072637 002 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 1989/12/05 SUN PHARM INDUSTRIES
072894 002 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 1991/01/17 MYLAN
208804 001 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2018/05/21 AMNEAL PHARMS CO
207046 001 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2018/06/29 APPCO PHARMA LLC
211397 001 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2018/10/26 VIRTUS PHARM
210948 001 ANDA ALBUTEROL SULFATE ALBUTEROL SULFATE TABLET;ORAL EQ 2MG BASE Prescription No No AB 2019/03/15 ARISE
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