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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 30/12/2025 | Siegfried AG |
Switzerland |
PENICK CORP | 9368 | CODEINE SULFATE | 1991-10-02 | Inactive | II | N/A | ||
| 30/12/2025 | Mallinckrodt Pharmaceuticals |
Ireland |
SPECGX LLC | 21117 | CODEINE SULFATE USP POWDER | 2007-11-30 | Active | II | Complete | 2014-08-04 | 2014-07-28 |
