药品注册申请号:085865
申请类型:ANDA (仿制药申请)
申请人:WATSON LABS
申请人全名:WATSON LABORATORIES 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 TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE INJECTABLE;INJECTION 4MG/ML;90MG/ML No No None 1981/05/07 Approved Prior to Jan 1, 1982 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
1999/02/19 SUPPL 35 Approval Manufacturing (CMC)
1999/02/02 SUPPL 34 Approval Manufacturing (CMC)
1997/12/08 SUPPL 33 Approval Manufacturing (CMC)
1996/12/04 SUPPL 32 Approval Manufacturing (CMC)
1996/08/20 SUPPL 31 Approval Labeling
1991/09/20 SUPPL 28 Approval Manufacturing (CMC)
1991/09/20 SUPPL 27 Approval Manufacturing (CMC)
1991/09/20 SUPPL 26 Approval Manufacturing (CMC)
1991/04/17 SUPPL 30 Approval Labeling
1990/07/24 SUPPL 29 Approval Labeling
1989/08/18 SUPPL 21 Approval Bioequivalence
1986/04/30 SUPPL 20 Approval Manufacturing (CMC)
1984/09/05 SUPPL 18 Approval Manufacturing (CMC)
1982/11/01 SUPPL 16 Approval Manufacturing (CMC)
1982/06/23 SUPPL 17 Approval Manufacturing (CMC)
1982/06/04 SUPPL 15 Approval Manufacturing (CMC)
1981/05/07 ORIG 1 Approval
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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与本品治疗等效的药品
本品无治疗等效药品
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