药品注册申请号:005970
申请类型:NDA (新药申请)
申请人:ELKINS SINN
申请人全名:ELKINS SINN DIV AH ROBINS CO 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
004 SOTRADECOL SODIUM TETRADECYL SULFATE INJECTABLE;INJECTION 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1946/08/13 Approved Prior to Jan 1, 1982 Discontinued
005 SOTRADECOL SODIUM TETRADECYL SULFATE INJECTABLE;INJECTION 3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
2001/03/09 SUPPL 37 Approval Manufacturing (CMC) PRIORITY
1991/09/18 SUPPL 35 Approval Labeling PRIORITY
1990/01/16 SUPPL 34 Approval Labeling PRIORITY
1989/01/12 SUPPL 33 Approval Labeling PRIORITY
1988/06/23 SUPPL 32 Approval Labeling PRIORITY
1988/01/29 SUPPL 28 Approval Labeling PRIORITY
1987/03/31 SUPPL 31 Approval Manufacturing (CMC) PRIORITY
1987/03/31 SUPPL 30 Approval Manufacturing (CMC) PRIORITY
1985/08/24 SUPPL 27 Approval Manufacturing (CMC) PRIORITY
1983/03/02 SUPPL 26 Approval Manufacturing (CMC) PRIORITY
1979/03/23 SUPPL 25 Approval Manufacturing (CMC) PRIORITY
1978/09/26 SUPPL 24 Approval Manufacturing (CMC) PRIORITY
1977/05/03 SUPPL 22 Approval Labeling PRIORITY
1976/03/16 SUPPL 19 Approval Labeling PRIORITY
1975/03/11 SUPPL 18 Approval Labeling PRIORITY
1975/02/03 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
1972/09/14 SUPPL 13 Approval Labeling PRIORITY
1946/08/13 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)
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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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