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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Laboratorium Ofichem B.V |
Netherlands |
LABORATORIUM OFICHEM BV | 36993 | EDETATE CALCIUM DISODIUM | 2022-07-13 | Active | II | Complete | 2022-08-30 | 2022-08-03 |
| 31/10/2025 | Akzo Nobel Polymer Chem LLC |
U.S.A |
AKZO NOBEL CHEMICALS BV | 10759 | DISSOLVINE E-CA-10 (EDETATE CALCIUM DISODIUM USP) | 1994-03-03 | Inactive | II | N/A |
