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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 28/03/2025 | Nuray Chemicals Private Limited |
India |
SS PHARMA LLC | 38890 | SODIUM PHENYLBUTYRATE USP | 2023-09-29 | Active | II | Complete | 2023-11-15 | 2023-09-27 |
| 28/03/2025 | Seqens |
France |
CU CHEMIE UETIKON GMBH | 9716 | 4-PHENYLBUTYRIC ACID SODIUM SALT | 1992-06-08 | Active | II | Complete | 2020-12-12 | 2020-12-08 |
