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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/11/2024 | ACS DOBFAR SPA |
Italy |
ACS DOBFAR SPA | 29102 | ERTAPENEM SODIUM | 2015-04-13 | Active | II | Complete | 2015-09-30 | 2015-04-17 |
28/11/2024 | Asymchem Laboratories |
U.S.A |
ASYMCHEM LABORATORIES FUXIN CO LTD | 29473 | ERTAPENEM SODIUM | 2015-06-12 | Inactive | II | N/A |
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