药品注册申请号:020613
申请类型:NDA (新药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN 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 ALPHAGAN BRIMONIDINE TARTRATE SOLUTION/DROPS;OPHTHALMIC 0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1996/09/06 1996/09/06 Discontinued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
2016/03/23 SUPPL-31(补充) Approval Labeling STANDARD
2013/06/06 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
2003/03/19 SUPPL-24(补充) Approval Labeling STANDARD
2002/05/16 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2002/04/12 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
2001/12/20 SUPPL-18(补充) Approval Efficacy STANDARD
2001/12/04 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
2001/07/13 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2001/05/14 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
2001/04/12 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
2001/04/09 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
2001/04/09 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
2000/10/02 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
2000/05/26 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1999/12/13 SUPPL-8(补充) Approval Labeling STANDARD
1999/12/13 SUPPL-6(补充) Approval Labeling STANDARD
1999/08/26 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1998/05/20 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1998/02/25 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1998/01/15 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1997/05/29 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1996/09/06 ORIG-1(原始申请) 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)
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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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