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List of Drug Master Files (DMF) of Aripiprazole Lauroxil 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 Polpharma
Poland
ZAKLADY FARMACEUTYCZNE POLPHARMA SA 31531 ARIPIPRAZOLE LAUROXIL 2018-08-16 Active II Complete 2018-12-10 2018-08-21
26/09/2024 Neuland Laboratories
India
NEULAND LABORATORIES LTD 32683 ARIPIPRAZOLE LAUROXIL 2018-03-31 Active II N/A