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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 | 38577 | CEVIMELINE HYDROCHLORIDE USP | 2023-09-28 | Active | II | Complete | 2023-11-13 | 2023-09-27 |
28/03/2025 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INC | 22509 | CEVIMELINE HYDROCHLORIDE HEMIHYDRATE | 2009-02-06 | Active | II | N/A |