Introduction:
There are Drug Master Files about the drugs approved by the U.S. Food and Drug Administration.
abbreviation of Status:
“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
abbreviation of Types:
Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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