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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
25/04/2025 | Nuray Chemicals Private Limited |
India |
SS PHARMA LLC | 31385 | TREPROSTINIL DIOLAMINE | 2017-02-28 | Active | II | Complete | 2017-03-17 | 2017-02-13 |
25/04/2025 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INC | 32086 | TREPROSTINIL DIETHANOLAMINE | 2017-10-05 | Active | II | Complete | 2018-03-09 | 2017-09-27 |