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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 |
SS PHARMA LLC | 38680 | ESTAZOLAM USP | 2023-09-23 | Active | II | Complete | 2023-11-06 | 2023-09-27 |
28/03/2025 | Cambrex Corporation |
U.S.A |
CAMBREX PROFARMACO MILANO SRL | 12228 | ESTAZOLAM | 1996-11-18 | Active | II | N/A |