药品注册申请号:011559
申请类型:NDA (新药申请)
申请人:PAR STERILE PRODUCTS
申请人全名:PAR STERILE PRODUCTS LLC
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 BREVITAL SODIUM METHOHEXITAL SODIUM INJECTABLE;INJECTION 500MG/VIAL Yes Yes None 1960/06/27 Approved Prior to Jan 1, 1982 Prescription
002 BREVITAL SODIUM METHOHEXITAL SODIUM INJECTABLE;INJECTION 2.5GM/VIAL Yes Yes None Approved Prior to Jan 1, 1982 Prescription
003 BREVITAL SODIUM METHOHEXITAL SODIUM INJECTABLE;INJECTION 5GM/VIAL No No None Approved Prior to Jan 1, 1982 Discontinued
004 BREVITAL SODIUM METHOHEXITAL SODIUM INJECTABLE;INJECTION 200MG/VIAL No No None 2012/12/21 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
2017/04/27 SUPPL 51 Approval Labeling STANDARD
2014/12/15 SUPPL 48 Approval Manufacturing (CMC) STANDARD
2014/09/22 SUPPL 47 Approval Manufacturing (CMC) STANDARD
2014/01/23 SUPPL 45 Approval Labeling STANDARD
2008/05/05 SUPPL 41 Approval Labeling STANDARD
2004/05/27 SUPPL 37 Approval Labeling STANDARD
2003/03/14 SUPPL 33 Approval Manufacturing (CMC) STANDARD
2001/07/13 SUPPL 32 Approval Labeling STANDARD
1998/01/30 SUPPL 29 Approval Efficacy UNKNOWN
1998/01/30 SUPPL 28 Approval Efficacy UNKNOWN
1997/12/17 SUPPL 30 Approval Labeling STANDARD
1996/07/25 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1996/02/29 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1995/11/02 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1994/06/14 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1992/12/18 SUPPL 18 Approval Labeling
1992/12/02 SUPPL 21 Approval Labeling STANDARD
1988/07/08 SUPPL 14 Approval Labeling
1981/07/01 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1979/10/04 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1976/05/14 SUPPL 9 Approval Labeling
1975/06/13 SUPPL 8 Approval Labeling
1969/12/11 SUPPL 4 Approval Labeling
1960/06/27 ORIG 1 Approval Type 1 - New Molecular Entity 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
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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