药品注册申请号:208143
申请类型:NDA (新药申请)
申请人:BRACCO
申请人全名:BRACCO DIAGNOSTICS 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 READI-CAT 2 BARIUM SULFATE SUSPENSION;ORAL 2% (9GM/BOT) Yes Yes None 2016/01/15 2016/01/15 Prescription
002 READI-CAT 2 SMOOTHIE BARIUM SULFATE SUSPENSION;ORAL 2% (9GM/BOT) Yes Yes None 2016/01/15 Prescription
003 LIQUID E-Z-PAQUE BARIUM SULFATE SUSPENSION;ORAL 60% (213GM/BOT) Yes Yes None 2017/03/01 Prescription
004 VARIBAR NECTAR BARIUM SULFATE SUSPENSION;ORAL 40% (96GM/240ML) Yes Yes None 2017/07/07 Prescription
005 TAGITOL V BARIUM SULFATE SUSPENSION;ORAL 40% (8GM/BOT) Yes Yes None 2017/08/04 Prescription
006 VARIBAR THIN HONEY BARIUM SULFATE SUSPENSION;ORAL 40% (100GM/250ML) Yes Yes None 2018/01/23 Prescription
007 VARIBAR HONEY BARIUM SULFATE SUSPENSION;ORAL 40% (100GM/250ML) Yes Yes None 2018/03/26 Prescription
008 ENTERO VU 24% BARIUM SULFATE SUSPENSION;ORAL 24% (144GM/600ML) Yes None -- 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
2020/05/29 SUPPL 11 Approval Efficacy STANDARD
2018/03/26 SUPPL 7 Approval Efficacy STANDARD
2018/01/23 SUPPL 6 Approval Efficacy STANDARD
2017/08/04 SUPPL 5 Approval Efficacy STANDARD Label for TAGITOL V
2017/07/07 SUPPL 4 Approval Efficacy STANDARD Label for VARIBAR NECTAR
2017/03/01 SUPPL 2 Approval Efficacy STANDARD
2017/02/08 SUPPL 3 Approval Labeling STANDARD
2016/01/15 ORIG 1 Approval Type 7 - Drug Already Marketed without Approved NDA 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
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