药品注册申请号:018578
申请类型:NDA (新药申请)
申请人:DR REDDYS LA
申请人全名:DR REDDYS LABORATORIES LOUISIANA LLC
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 SSD SILVER SULFADIAZINE CREAM;TOPICAL 1% No No AB 1982/02/25 1982/02/25 Prescription
003 SSD AF SILVER SULFADIAZINE CREAM;TOPICAL 1% No No None 1990/07/11 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
2014/04/21 SUPPL 16 Approval Manufacturing (CMC) STANDARD
2000/05/24 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1999/01/12 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1995/01/11 SUPPL 11 Approval Manufacturing (CMC) STANDARD
1990/08/03 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1990/07/11 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1990/07/11 SUPPL 6 Approval Labeling
1989/03/15 SUPPL 7 Approval Manufacturing (CMC) STANDARD
1985/12/10 SUPPL 5 Approval Labeling
1985/01/29 SUPPL 1 Approval Manufacturing (CMC) STANDARD
1984/03/16 SUPPL 4 Approval Manufacturing (CMC) STANDARD
1983/08/19 SUPPL 3 Approval Labeling
1983/05/12 SUPPL 2 Approval Manufacturing (CMC) STANDARD
1982/02/25 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
活性成分:SILVER SULFADIAZINE 剂型/给药途径:CREAM;TOPICAL 规格:1% 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
017381 001 NDA SILVADENE SILVER SULFADIAZINE CREAM;TOPICAL 1% Prescription Yes Yes AB Approved Prior to Jan 1, 1982 KING PHARMS LLC
018578 001 NDA SSD SILVER SULFADIAZINE CREAM;TOPICAL 1% Prescription No No AB 1982/02/25 DR REDDYS LA
018810 001 NDA THERMAZENE SILVER SULFADIAZINE CREAM;TOPICAL 1% Prescription No No AB 1985/12/23 THEPHARMANETWORK LLC
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