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List of Drug Master Files (DMF) of Amphotericin B 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 Ajinomoto Company
Japan
SHANGHAI ASIA PIONEER CO LTD 13224 AMPHOTERICIN B 1998-04-30 Inactive II N/A
26/09/2024 Asence Pharma
India
ASENCE PHARMA PRIVATE LTD 26375 AMPHOTERICIN B USP [INTENDED FOR USE IN PREPARING PARENTERAL DOSAGE FORMS] 2012-09-05 Active II N/A