药品注册申请号:019774
申请类型:BLA (生物制品许可申请)
申请人:FERRING
申请人全名:--
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 BIO-TROPIN SOMATROPIN INJECTABLE;INJECTION 4.8MG/VIAL No None 1995/05/25 -- Discontinued
002 ZOMACTON SOMATROPIN INJECTABLE;INJECTION 5MG/VIAL No None -- Prescription
003 ZOMACTON SOMATROPIN INJECTABLE;INJECTION 10MG/VIAL No None -- 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
2020/03/13 SUPPL 53 Approval Labeling STANDARD
2018/07/19 SUPPL 51 Approval Efficacy STANDARD
2018/07/19 SUPPL 50 Approval Efficacy STANDARD
2018/07/19 SUPPL 49 Approval Efficacy STANDARD
2018/07/19 SUPPL 48 Approval Efficacy STANDARD
2018/01/30 SUPPL 47 Approval Labeling STANDARD
2018/01/30 SUPPL 45 Approval Efficacy STANDARD
2018/01/30 SUPPL 40 Approval Efficacy STANDARD
2018/01/30 SUPPL 29 Approval Labeling STANDARD
2017/01/10 SUPPL 37 Approval Labeling STANDARD
2016/12/13 SUPPL 38 Approval Labeling STANDARD
2016/09/30 SUPPL 36 Approval Labeling STANDARD
2016/02/26 SUPPL 34 Approval Manufacturing (CMC) STANDARD
2015/08/06 SUPPL 30 Approval Manufacturing (CMC) STANDARD
2015/07/30 SUPPL 32 Approval Manufacturing (CMC) STANDARD
2015/06/12 SUPPL 31 Approval Labeling STANDARD
2015/03/04 SUPPL 26 Approval Labeling STANDARD
2014/10/29 SUPPL 28 Approval Labeling STANDARD
2014/06/18 SUPPL 27 Approval Labeling STANDARD
2011/07/19 SUPPL 23 Approval Labeling STANDARD
2010/04/12 SUPPL 19 Approval Labeling UNKNOWN
2009/06/25 SUPPL 16 Approval Manufacturing (CMC) N/A
2007/02/15 SUPPL 14 Approval Labeling STANDARD
2005/03/16 SUPPL 9 Approval Labeling STANDARD
2002/04/09 SUPPL 7 Approval Manufacturing (CMC) STANDARD
2002/01/04 SUPPL 8 Approval Manufacturing (CMC) STANDARD
2000/08/17 SUPPL 6 Approval Labeling STANDARD
2000/02/03 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1999/11/03 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1996/09/09 SUPPL 3 Approval Manufacturing (CMC) STANDARD
1996/08/29 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1995/05/25 ORIG 1 Approval Type 5 - New Formulation or New Manufacturer 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
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