DMF提交信息庫
使用說明:
項目狀態(tài)檢索標(biāo)識及釋義:
“A” = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
“I” = Inactive
“N” = Not an assigned number
“P” = DMF Pending Filing Review
項目類型檢索標(biāo)識及釋義:
Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Ⅱ Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Ⅲ Packaging Material
Ⅳ Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Ⅴ FDA Accepted Reference Information
1 本數(shù)據(jù)庫收錄了向美國FDA提交的藥物主文檔(Drug Master File,DMF)目錄。
2 您可以在DMF提交信息庫中搜索DMF號、項目持有人(Holder)、項目名稱(Subject)。
項目持有人舉例如下:
項目狀態(tài)檢索標(biāo)識及釋義:
“A” = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
“I” = Inactive
“N” = Not an assigned number
“P” = DMF Pending Filing Review
項目類型檢索標(biāo)識及釋義:
Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Ⅱ Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Ⅲ Packaging Material
Ⅳ Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Ⅴ FDA Accepted Reference Information
