|DMF Subject||Type||Status||DMF Holder||Completeness Assessment (Date)||DMF#||Submission Date|
A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
You can search details of DMF(s) listed at FDA along with below information.
Completeness AssessmentType II DMFs to support ANDAs under GDUFA are subject to an initial "Completeness Assessment" under the conditions specified in the below guidance.
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