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List of Drug Master Files (DMF) of Tox21_300633 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 398Xls download

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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 Boehringer Ingelheim GmbH
Germany
BOEHRINGER INGELHEIM CHEMICALS INC 13942 METHADONE HYDROCHLORIDE USP 1999-01-18 Inactive II N/A
26/09/2024 Chattem Chemicals, Inc
U.S.A
CHATTEM CHEMICALS INC 25286 METHADONE HYDROCHLORIDE USP 2012-05-09 Active II Complete 2014-09-25 2012-12-28