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        1. FDA's Drug Master Files

          Drug Master Files

          • DMF Holder  Subject

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          Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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