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List of Drug Master Files (DMF) of Sodium 4-Hydroxy-3-Phenylbutanoate 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 Sri Krishna Pharmaceuticals
India
SRI KRISHNA PHARMACEUTICALS LTD 19569 SODIUM PHENYLBUTYRATE USP 2006-06-30 Active II Complete 2019-07-09 2019-07-03