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        Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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