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List of Drug Master Files (DMF) of Novobiocin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
26/09/2024 Pfizer CentreOne
U.S.A
PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC 13334 NOVOBIOCIN SODIUM 1998-09-01 Active II N/A