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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 | Actavis Inc |
Ireland |
ACTAVIS GROUP PTC EHF | 22983 | ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE) | 2009-07-24 | Active | II | N/A | ||
28/03/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 27302 | ARMODAFINIL | 2013-07-29 | Active | II | Complete | 2013-08-28 | 2013-07-24 |