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使用說明：

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：

Ampacet Corp	Basf Aktiengesellschaft	Cipla Ltd
Dr Reddys Laboratories Ltd	Diosynth Bv	Flavors North America Inc
Chemicals Inc	Mallinckrodt Inc	Matrix Laboratories Ltd
Polyone Corp	Ranbaxy Laboratories Ltd	Sun Pharmaceutical Industries Ltd
Teva Pharmaceutical Industries Ltd	Sigma F And D Div Ltd

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Ⅰ　Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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