药品注册申请号:017849
申请类型:NDA (新药申请)
申请人:ANI PHARMS INC
申请人全名:ANI PHARMACEUTICALS 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 BRETHINE TERBUTALINE SULFATE TABLET;ORAL 2.5MG Yes No AB 1976/05/17 Approved Prior to Jan 1, 1982 Prescription
002 BRETHINE TERBUTALINE SULFATE TABLET;ORAL 5MG Yes No AB Approved Prior to Jan 1, 1982 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
2011/04/08 SUPPL 40 Approval Labeling 901 REQUIRED
2003/12/19 SUPPL 39 Approval Labeling STANDARD
2002/05/28 SUPPL 37 Approval Manufacturing (CMC) STANDARD
2002/03/04 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1999/04/23 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1999/02/08 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1999/02/02 SUPPL 32 Approval Labeling STANDARD
1997/09/09 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1997/07/07 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1997/02/25 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1996/02/23 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1995/12/18 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1995/11/14 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1995/03/24 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1993/02/09 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1992/07/16 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1986/01/31 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1984/05/16 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1984/05/16 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1984/05/16 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1982/03/22 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1981/06/06 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1980/11/05 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1980/06/25 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1980/06/04 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1980/02/13 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1979/05/24 SUPPL 7 Approval Labeling
1979/04/03 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1979/04/03 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1979/04/03 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1979/01/03 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1979/01/03 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1977/03/08 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1977/03/08 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1977/03/08 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1976/05/17 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer STANDARD
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:TERBUTALINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:2.5MG 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
017849 001 NDA BRETHINE TERBUTALINE SULFATE TABLET;ORAL 2.5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 ANI PHARMS INC
075877 001 ANDA TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET;ORAL 2.5MG Prescription No No AB 2001/06/26 IMPAX LABS
077152 001 ANDA TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET;ORAL 2.5MG Prescription No No AB 2005/03/25 LANNETT CO INC
211832 001 ANDA TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET;ORAL 2.5MG Prescription No No AB 2020/06/19 TWI PHARMS
活性成分:TERBUTALINE SULFATE 剂型/给药途径:TABLET;ORAL 规格:5MG 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
017849 002 NDA BRETHINE TERBUTALINE SULFATE TABLET;ORAL 5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 ANI PHARMS INC
075877 002 ANDA TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET;ORAL 5MG Prescription No No AB 2001/06/26 IMPAX LABS
077152 002 ANDA TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET;ORAL 5MG Prescription No Yes AB 2005/03/25 LANNETT CO INC
211832 002 ANDA TERBUTALINE SULFATE TERBUTALINE SULFATE TABLET;ORAL 5MG Prescription No No AB 2020/06/19 TWI PHARMS
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