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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
29/11/2025 Enaltec Labs
India
ENALTEC LABS PRIVATE LTD 30806 MIDODRINE HYDROCHLORIDE USP 2016-09-27 Active II Complete 2017-03-17 2016-09-26
29/11/2025 Mankind Pharma
India
MANKIND PHARMA LTD 40408 MIDODRINE HYDROCHLORIDE USP 2024-11-18 Active II Complete 2025-01-16 2025-01-06