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List of Drug Master Files (DMF) of Loxapine 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 Medichem S.A
Spain
MEDICHEM SA 23144 LOXAPINE BASE 2009-09-30 Active II N/A
26/09/2024 IDT Australia Limited
Australia
INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTD 13135 LOXAPINE BASE 1998-08-14 Inactive II N/A