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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 | Sanofi |
France |
SANOFI CHIMIE | 9382 | ACEBUTOLOL HYDROCHLORIDE | 1991-10-23 | Inactive | II | N/A | ||
| 28/03/2025 | Nuray Chemicals Private Limited |
India |
SS PHARMA LLC | 35857 | ACEBUTOLOL HYDROCHLORIDE USP | 2021-04-30 | Active | II | Complete | 2021-06-16 | 2021-04-30 |
