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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
29/07/2025 | Supriya Lifescience |
India |
SUPRIYA LIFESCIENCE LTD | 33575 | DEXTROMETHORPHAN HYDROBROMIDE USP | 2019-03-25 | Active | II | Complete | 2025-07-08 | 2025-04-09 |
29/07/2025 | Malladi Drugs & Pharmaceuticals Limited |
India |
MALLADI DRUGS AND PHARMACEUTICALS LTD | 32402 | DEXTROMETHORPHAN HYDROBROMIDE | 2018-01-04 | Active | II | Complete | 2019-05-28 | 2019-04-25 |