药品注册申请号:083734
申请类型:ANDA (仿制药申请)
申请人:ANI PHARMS
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 PROBENECID AND COLCHICINE COLCHICINE; PROBENECID TABLET;ORAL 0.5MG;500MG No No None 1978/06/12 Approved Prior to Jan 1, 1982 Discontinued
批准日期,申请提交历史,通知信,药品说明书,审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级;罕用药状态通知信、审评文件、说明书、包装标签备注
2002/07/29 SUPPL-47(补充) Approval Manufacturing (CMC)
2002/03/12 SUPPL-46(补充) Approval Manufacturing (CMC)
2001/07/11 SUPPL-44(补充) Approval Manufacturing (CMC)
2001/07/11 SUPPL-42(补充) Approval Manufacturing (CMC)
2001/07/11 SUPPL-41(补充) Approval Manufacturing (CMC)
2001/07/11 SUPPL-40(补充) Approval Manufacturing (CMC)
2000/01/28 SUPPL-43(补充) Approval Manufacturing (CMC)
1999/08/20 SUPPL-39(补充) Approval Manufacturing (CMC)
1998/12/09 SUPPL-38(补充) Approval Manufacturing (CMC)
1997/05/30 SUPPL-37(补充) Approval Manufacturing (CMC)
1996/02/05 SUPPL-35(补充) Approval Manufacturing (CMC)
1993/08/03 SUPPL-36(补充) Approval Manufacturing (CMC)
1990/01/05 SUPPL-34(补充) Approval Labeling
1988/01/20 SUPPL-33(补充) Approval Manufacturing (CMC)
1988/01/20 SUPPL-32(补充) Approval Manufacturing (CMC)
1988/01/20 SUPPL-31(补充) Approval Manufacturing (CMC)
1987/03/03 SUPPL-30(补充) Approval Manufacturing (CMC)
1987/03/03 SUPPL-29(补充) Approval Manufacturing (CMC)
1978/06/12 ORIG-1(原始申请) 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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