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List of Drug Master Files (DMF) of Amoxicilline Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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$ API Ref.Price (USD/KG) : 128Xls download

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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 Aurobindo Pharma Limited
India
APITORIA PHARMA PRIVATE LTD 39198 AMOXICILLIN SODIUM (NON-STERILE) 2023-12-01 Active II Complete 2024-01-05 2023-11-28
26/09/2024 Aurobindo Pharma Limited
India
AUROBINDO PHARMA LTD 20128 AMOXICILLIN SODIUM (STERILE) BULK 2006-12-30 Inactive II N/A