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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 Aarti Drugs
India
AARTI DRUGS LTD 29858 ROFECOXIB 2015-09-29 Inactive II N/A
24/02/2025 Shasun Chemicals and Drugs Ltd
India
SHASUN CHEMICALS AND DRUGS LTD 16617 ROFECOXIB 2003-05-19 Inactive II N/A