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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 13250 CIPROFLOXACIN HYDROCHLORIDE USP 1998-09-29 Active II Complete 2012-10-26 2012-12-13
28/03/2025 Aarti Drugs
India
AARTI DRUGS LTD 19611 CIPROFLOXACIN HYDROCHLORIDE 2006-07-17 Active II Complete 2014-06-16 2014-06-09