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                    Ⅰ Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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