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List of Drug Master Files (DMF) of Dyphylline 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 Shanghai Wonder Pharmaceutical
China
SHANGHAI WONDER PHARMACEUTICAL CO LTD 34679 DYPHYLLINE 2020-03-16 Active II N/A
26/09/2024 CENTRAL PHARMACAL CO 3793 DYPHYLLINE SUSTAINED RELEASE CAPSULES 1980-03-13 Inactive II N/A