FDA's Drug Master Files

Drug Master Files

  • DMF Holder  Subject
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Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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