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使用说明:
1 本数据库收录了向美国FDA提交的药物主文档(Drug Master File,DMF)目录。
2 您可以在DMF提交信息库中搜索DMF号、项目持有人(Holder)、项目名称(Subject)。
项目持有人举例如下:
项目状态检索标识及释义:
“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
项目类型检索标识及释义:
Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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