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List of Drug Master Files (DMF) of Hyospaz 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 Boehringer Ingelheim GmbH
Germany
BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG 9351 HYOSCYAMINE SULFATE 1991-09-06 Inactive II N/A
26/09/2024 Hubei Biocause Heilen Pharmaceutical Co., Ltd
China
HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD 28614 HYOSCYAMINE SULFATE 2014-09-02 Active II N/A