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List of Drug Master Files (DMF) of Neothramycins 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 Meiji Seika Pharma
Japan
MEIJI SEIKA KAISHA LTD 4577 NEOTHRAMYCIN, BULK 1982-04-30 Inactive II N/A
26/09/2024 Meiji Seika Pharma
Japan
MEIJI SEIKA KAISHA LTD 4564 NEOTHRAMYCIN 1982-05-14 Inactive II N/A