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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 | 28148 | FINGOLIMOD HYDROCHLORIDE | 2014-04-27 | Active | II | Complete | 2014-08-20 | 2014-04-25 |
28/03/2025 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 28057 | FINGOLIMOD HYDROCHLORIDE USP | 2014-03-28 | Active | II | Complete | 2014-06-10 | 2014-03-24 |