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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Aarti Drugs |
India |
AARTI DRUGS LTD | 29858 | ROFECOXIB | 2015-09-29 | Inactive | II | N/A | ||
| 31/10/2025 | Shasun Chemicals and Drugs Ltd |
India |
SHASUN CHEMICALS AND DRUGS LTD | 16617 | ROFECOXIB | 2003-05-19 | Inactive | II | N/A |
