DMF提交信息庫(kù)
使用說(shuō)明:
項(xiàng)目狀態(tài)檢索標(biāo)識(shí)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(xiàng)目類型檢索標(biāo)識(shí)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Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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(kù)收錄了向美國(guó)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(kù)中搜索DMF號(hào)、項(xiàng)目持有人(Holder)、項(xiàng)目名稱(Subject)。
項(xiàng)目持有人舉例如下:
項(xiàng)目狀態(tài)檢索標(biāo)識(shí)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(xiàng)目類型檢索標(biāo)識(shí)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Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
