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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
24/02/2025 Neuland Laboratories
India
NEULAND LABORATORIES LTD 38770 MIRABEGRON 2023-08-31 Active II N/A
24/02/2025 Dr. Reddy\'s Laboratories
India
DR REDDYS LABORATORIES LTD 28392 MIRABEGRON [PRODUCT CODE: AEB] 2014-06-30 Active II Complete 2014-09-29 2014-07-14