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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
04/06/2025 | Unimark Remedies |
India |
UNIMARK REMEDIES LTD | 24945 | ARMODAFINIL | 2011-06-01 | Active | II | Complete | 2014-08-05 | 2014-01-22 |
04/06/2025 | Actavis Inc |
Ireland |
ACTAVIS GROUP PTC EHF | 22983 | ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE) | 2009-07-24 | Active | II | N/A |