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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 25/04/2025 | Chattem Chemicals, Inc |
U.S.A |
CHATTEM CHEMICALS INC | 32354 | DIHYDROCODEINE BITARTRATE USP | 2019-09-27 | Active | II | N/A | ||
| 25/04/2025 | Mallinckrodt Pharmaceuticals |
Ireland |
SPECGX LLC | 191 | PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) | 1956-01-24 | Active | II | Complete | 2012-10-24 | 2012-12-04 |
