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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 | Andhra Organics Limited. |
India |
ANDHRA ORGANICS LTD | 38268 | SULFADIAZINE USP | 2023-05-12 | Active | II | Complete | 2024-08-21 | 2024-08-13 |
28/03/2025 | Hunan Xiangyikang Pharmaceutical |
China |
HUNAN XIANGYIKANG PHARMACEUTICAL CO LTD | 33237 | SULFADIAZINE USP | 2018-12-13 | Active | II | Complete | 2020-07-14 | 2020-06-19 |