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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 | Nuray Chemicals Private Limited |
India |
NOVITIUM PHARMA LLC | 31920 | OXANDROLONE USP | 2017-10-28 | Active | II | Complete | 2017-12-05 | 2017-07-28 |
28/03/2025 | Curia |
U.S.A |
CURIA ITALY SRL | 34723 | OXANDROLONE | 2020-03-17 | Active | II | N/A |