药品注册申请号:072972
申请类型:ANDA (仿制药申请)
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 SULINDAC SULINDAC TABLET;ORAL 150MG No No None 1992/02/28 1992/02/28 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
2016/05/09 SUPPL 21 Approval Labeling STANDARD
2001/08/30 SUPPL 20 Approval Manufacturing (CMC)
1996/12/13 SUPPL 19 Approval Manufacturing (CMC)
1996/08/16 SUPPL 18 Approval Manufacturing (CMC)
1995/11/20 SUPPL 14 Approval Manufacturing (CMC)
1995/11/20 SUPPL 13 Approval Manufacturing (CMC)
1995/11/20 SUPPL 12 Approval Manufacturing (CMC)
1995/10/03 SUPPL 17 Approval Manufacturing (CMC)
1995/10/03 SUPPL 16 Approval Manufacturing (CMC)
1995/10/03 SUPPL 15 Approval Manufacturing (CMC)
1995/07/28 SUPPL 4 Approval Labeling
1995/03/02 SUPPL 11 Approval Manufacturing (CMC)
1994/01/26 SUPPL 10 Approval Manufacturing (CMC)
1994/01/26 SUPPL 9 Approval Manufacturing (CMC)
1994/01/26 SUPPL 8 Approval Manufacturing (CMC)
1994/01/26 SUPPL 7 Approval Manufacturing (CMC)
1994/01/26 SUPPL 6 Approval Manufacturing (CMC)
1994/01/26 SUPPL 5 Approval Manufacturing (CMC)
1993/05/24 SUPPL 1 Approval Manufacturing (CMC)
1993/04/01 SUPPL 3 Approval Manufacturing (CMC)
1993/04/01 SUPPL 2 Approval Manufacturing (CMC)
1992/02/28 ORIG 1 Approval
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
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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