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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
24/02/2025 | Alembic Pharmaceuticals Limited |
India |
ALEMBIC PHARMACEUTICALS LTD | 16112 | LEFLUNOMIDE USP | 2002-08-29 | Active | II | N/A | ||
24/02/2025 | Cipla |
India |
CIPLA LTD | 16109 | LEFLUNOMIDE USP | 2002-08-23 | Active | II | Complete | 2016-02-18 | 2015-08-21 |