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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
28/03/2025 Neuland Laboratories
India
NEULAND LABORATORIES LTD 15433 OFLOXACIN USP 2001-05-15 Active II Complete 2015-10-26 2015-10-15
28/03/2025 Cambrex Corporation
U.S.A
CAMBREX CHARLES CITY INC 14928 OFLOXACIN USP 2000-06-19 Active II Complete 2016-03-25 2016-03-02