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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 Aarti Pharmalabs
India
AARTI PHARMALABS LTD 21179 IPRATROPIUM BROMIDE 2007-12-15 Active II N/A
28/03/2025 Neuland Laboratories
India
NEULAND LABORATORIES LTD 15130 IPRATROPIUM BROMIDE USP 2000-11-06 Active II Complete 2014-01-15 2014-01-03