药品注册申请号:012813
申请类型:NDA (新药申请)
申请人:ALLERGAN
申请人全名:ALLERGAN PHARMACEUTICAL
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
002 BLEPHAMIDE PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM SUSPENSION;OPHTHALMIC 0.2%;10% Yes Yes None 1961/09/18 Approved Prior to Jan 1, 1982 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
2017/07/18 SUPPL 62 Approval Labeling STANDARD
2003/03/19 SUPPL 57 Approval Labeling STANDARD
2002/04/12 SUPPL 54 Approval Manufacturing (CMC) STANDARD
2001/12/04 SUPPL 53 Approval Manufacturing (CMC) STANDARD
2001/04/12 SUPPL 52 Approval Manufacturing (CMC) STANDARD
2001/03/26 SUPPL 51 Approval Manufacturing (CMC) STANDARD
2000/10/02 SUPPL 50 Approval Manufacturing (CMC) STANDARD
2000/04/21 SUPPL 49 Approval Manufacturing (CMC) STANDARD
2000/04/21 SUPPL 48 Approval Manufacturing (CMC) STANDARD
1999/12/03 SUPPL 47 Approval Manufacturing (CMC) STANDARD
1998/08/03 SUPPL 43 Approval Labeling STANDARD
1998/08/03 SUPPL 29 Approval Manufacturing (CMC) STANDARD
1998/05/21 SUPPL 45 Approval Manufacturing (CMC) STANDARD
1998/01/09 SUPPL 46 Approval Manufacturing (CMC) STANDARD
1997/09/30 SUPPL 44 Approval Manufacturing (CMC) STANDARD
1996/12/02 SUPPL 42 Approval Manufacturing (CMC) STANDARD
1995/08/03 SUPPL 40 Approval Manufacturing (CMC) STANDARD
1994/06/22 SUPPL 41 Approval Manufacturing (CMC) STANDARD
1993/04/13 SUPPL 39 Approval Manufacturing (CMC) STANDARD
1990/08/06 SUPPL 38 Approval Manufacturing (CMC) STANDARD
1989/11/07 SUPPL 37 Approval Manufacturing (CMC) STANDARD
1989/03/14 SUPPL 36 Approval Manufacturing (CMC) STANDARD
1986/11/10 SUPPL 35 Approval Manufacturing (CMC) STANDARD
1986/07/18 SUPPL 33 Approval Manufacturing (CMC) STANDARD
1986/07/07 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1986/03/14 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1985/08/23 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1985/07/09 SUPPL 30 Approval Manufacturing (CMC) STANDARD
1982/09/15 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1982/09/15 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1981/09/25 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1980/05/08 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1978/11/07 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1961/09/18 ORIG 1 Approval Type 4 - New Combination 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
©2006-2020 DrugFuture->U.S. FDA Drugs Database