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List of Drug Master Files (DMF) of Bacampicillin 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 Kyongbo Pharmaceutical Co., Ltd
South Korea
KYONGBO PHARMACEUTICAL CO LTD 17625 BACAMPICILLIN HYDROCHLORIDE NON-STERILE, BULK 2004-08-16 Inactive II N/A
26/09/2024 Pfizer Inc
U.S.A
ASTRA LAKEMEDEL AB 13590 BACAMPICILLIN HYDROCHLORIDE 1998-09-01 Inactive II N/A