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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
27/02/2026 Coral Drugs Private Limited
India
CORAL DRUGS PRIVATE LTD 36205 AZELASTINE HYDROCHLORIDE USP 2021-10-09 Active II Complete 2023-11-01 2023-09-22
27/02/2026 Curia
U.S.A
CURIA ITALY SRL 19422 AZELASTINE HYDROCHLORIDE 2006-05-05 Active II Complete 2014-01-27 2014-01-16