药品注册申请号:019107
申请类型:NDA (新药申请)
申请人:GENENTECH
申请人全名:GENENTECH 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 PROTROPIN SOMATREM INJECTABLE;INJECTION 5MG/VIAL No No None 1985/10/17 1985/10/17 Discontinued
002 PROTROPIN SOMATREM INJECTABLE;INJECTION 10MG/VIAL No No None 1989/10/24 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
2001/09/17 SUPPL 50 Approval Manufacturing (CMC) PRIORITY
2001/05/02 SUPPL 49 Approval Manufacturing (CMC) PRIORITY
2001/02/12 SUPPL 48 Approval Labeling PRIORITY
1999/11/03 SUPPL 46 Approval Manufacturing (CMC) PRIORITY
1999/05/21 SUPPL 47 Approval Manufacturing (CMC) PRIORITY
1998/10/22 SUPPL 44 Approval Manufacturing (CMC) PRIORITY
1998/10/07 SUPPL 45 Approval Manufacturing (CMC) PRIORITY
1995/09/22 SUPPL 41 Approval Manufacturing (CMC) PRIORITY
1995/08/21 SUPPL 43 Approval Labeling PRIORITY
1995/05/17 SUPPL 42 Approval Labeling PRIORITY
1995/04/05 SUPPL 40 Approval Labeling PRIORITY
1994/08/03 SUPPL 38 Approval Manufacturing (CMC) PRIORITY
1994/07/21 SUPPL 37 Approval Manufacturing (CMC) PRIORITY
1994/04/07 SUPPL 36 Approval Manufacturing (CMC) PRIORITY
1994/04/07 SUPPL 35 Approval Manufacturing (CMC) PRIORITY
1994/03/09 SUPPL 34 Approval Manufacturing (CMC) PRIORITY
1993/03/31 SUPPL 31 Approval Manufacturing (CMC) PRIORITY
1993/03/31 SUPPL 30 Approval Manufacturing (CMC) PRIORITY
1992/10/28 SUPPL 29 Approval Manufacturing (CMC) PRIORITY
1992/08/03 SUPPL 28 Approval Manufacturing (CMC) PRIORITY
1992/04/08 SUPPL 26 Approval Manufacturing (CMC) PRIORITY
1992/01/21 SUPPL 27 Approval Manufacturing (CMC) PRIORITY
1991/01/16 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1990/11/26 SUPPL 23 Approval Manufacturing (CMC) PRIORITY
1990/11/02 SUPPL 24 Approval Labeling PRIORITY
1990/10/15 SUPPL 20 Approval Manufacturing (CMC) PRIORITY
1990/05/25 SUPPL 21 Approval Manufacturing (CMC) PRIORITY
1990/03/23 SUPPL 19 Approval Manufacturing (CMC) PRIORITY
1989/11/06 SUPPL 18 Approval Manufacturing (CMC) PRIORITY
1989/11/06 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
1989/10/24 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
1989/10/24 SUPPL 4 Approval Manufacturing (CMC) PRIORITY
1989/05/23 SUPPL 14 Approval Manufacturing (CMC) PRIORITY
1989/02/01 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
1988/12/02 SUPPL 13 Approval Manufacturing (CMC) PRIORITY
1988/11/28 SUPPL 5 Approval Manufacturing (CMC) PRIORITY
1988/11/18 SUPPL 6 Approval Efficacy PRIORITY
1988/10/26 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
1988/06/14 SUPPL 11 Approval Manufacturing (CMC) PRIORITY
1988/06/14 SUPPL 10 Approval Manufacturing (CMC) PRIORITY
1988/03/08 SUPPL 9 Approval Manufacturing (CMC) PRIORITY
1988/03/08 SUPPL 8 Approval Manufacturing (CMC) PRIORITY
1986/11/20 SUPPL 3 Approval Labeling PRIORITY
1986/09/16 SUPPL 1 Approval Manufacturing (CMC) PRIORITY
1985/10/17 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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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