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List of Drug Master Files (DMF) of alpha-(Hydroxymethyl)benzeneacetic acid 9-methyl-3-oxa-9-azatricyclo(3.3.1.0(2.4))non-7-yl ester 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 Alchem International Private Ltd
India
ALCHEM INTERNATIONAL PRIVATE LTD 30687 HYOSCINE EP (SCOPOLAMINE) 2016-07-06 Active II Complete 2017-09-14 2017-06-02
26/09/2024 Phytex Australia
Australia
PHYTEX AUSTRALIA PARTY LTD 7408 SCOPOLAMINE BASE 1988-03-30 Active II Complete 2016-05-06 2015-06-30