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List of Drug Master Files (DMF) of Prestwick3_001089 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 Eli Lilly
U.S.A
ELI LILLY AND CO 13686 CYCLOSERINE 1998-09-01 Inactive II N/A
26/09/2024 Fermenta Biotech Limited
India
FERMENTA PRODUCTS INC 13571 CYCLOSERINE 1998-09-01 Inactive II N/A