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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 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 27048 | PRASUGREL HYDROCHLORIDE | 2013-06-12 | Active | II | Complete | 2013-07-30 | 2013-04-09 |
28/03/2025 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 25898 | PRASUGREL HYDROCHLORIDE | 2012-03-21 | Active | II | Complete | 2013-08-12 | 2013-05-17 |