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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 | Macrocyclics |
U.S.A |
MACROCYCLICS INC | 35952 | DOTAMTATE DRUG SUBSTANCE | 2021-05-20 | Active | II | N/A | ||
| 28/03/2025 | Oranomed |
U.S.A |
ORANO MED THERANOSTICS LLC | 35863 | 212Pb-DOTAMTATE DRUG PRODUCT | 2021-05-20 | Active | II | N/A |
