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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/01/2026 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 37565 | FOSPHENYTOIN SODIUM USP | 2023-03-20 | Active | II | Complete | 2023-05-03 | 2023-03-30 |
| 29/01/2026 | Cilag AG |
Switzerland |
CILAG AG | 18954 | FOSPHENYTOIN SODIUM DRUG SUBSTANCE (ACTIVE PHARMACEUTICAL INGREDIENT) | 2005-11-14 | Inactive | II | N/A |
