药品注册申请号:018571
申请类型:NDA (新药申请)
申请人:PHARMACARE
申请人全名:PHARMACARE 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 BRETHINE TERBUTALINE SULFATE INJECTABLE;INJECTION 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1981/11/30 Approved Prior to Jan 1, 1982 Discontinued
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 23 Approval Labeling 901 REQUIRED
2003/12/19 SUPPL 19 Approval Labeling STANDARD
2002/01/25 SUPPL 17 Approval Manufacturing (CMC) STANDARD
2001/08/17 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2000/03/21 SUPPL 15 Approval Labeling STANDARD
1998/12/11 SUPPL 10 Approval Labeling STANDARD
1998/12/09 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1998/09/17 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1998/03/12 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1997/11/19 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1997/09/09 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1997/07/07 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1996/02/13 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1995/07/05 SUPPL 6 Approval Manufacturing (CMC) STANDARD
1989/02/09 SUPPL 2 Approval Labeling
1989/02/09 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1984/08/17 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1981/11/30 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)
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与本品相关的市场独占权保护信息
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与本品治疗等效的药品
本品无治疗等效药品
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