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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 | Agno Pharma |
U.S.A |
AGNO PHARMA | 42166 | SULINDAC | 2025-07-11 | Active | II | Complete | 2025-09-26 | 2025-09-08 |
| 31/10/2025 | Agno Pharma |
U.S.A |
AGNO PHARMA USA | 20104 | SULINDAC | 2006-12-28 | Inactive | II | N/A |
