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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/11/2025 | Alkaloida Chemical Company Zrt |
Hungary |
ALKALOIDA CHEMICAL CO ZRT | 34598 | PHENOBARBITAL SODIUM, USP | 2020-03-10 | Active | II | Complete | 2020-03-31 | 2020-03-06 |
| 29/11/2025 | Harman Finochem |
India |
HARMAN FINOCHEM LTD | 31499 | PHENOBARBITAL SODIUM USP | 2017-03-16 | Active | II | N/A |
