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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Lunan Pharmaceutical |
China |
SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 35057 | OTERACIL POTASSIUM | 2021-01-23 | Active | II | N/A | ||
| 31/10/2025 | Sumitomo Chemical |
Japan |
SUMITOMO CHEMICAL CO LTD | 13908 | POTASSIUM OTASTAT | 1998-12-22 | Inactive | II | N/A |
