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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 04/06/2025 | ACS DOBFAR SPA |
Italy |
ACS DOBFAR SPA | 16452 | SULBACTAM SODIUM USP (STERILE BULK) | 2003-03-07 | Active | II | N/A | ||
| 04/06/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 19608 | SULBACTAM SODIUM USP (NON-STERILE BULK) | 2006-07-10 | Active | II | N/A |
