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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 07/08/2025 | Lee Pharma |
India |
LEE PHARMA LTD | 38431 | RALTEGRAVIR INTERMEDIATE "BENZYL (2-(4-(4-FLUOROBENZYL) CARBAMOYL)-5-HYDROXY-1-METHYL-6-OXO-1, 6-DIHYDRO- PYRIMIDIN-2-YL) PROPAN-2-YL) CARBAMATE" | 2023-05-25 | Active | II | N/A | ||
| 29/07/2025 | Maithri Drugs |
India |
MAITHRI DRUGS PRIVATE LTD | 36083 | RALTEGRAVIR POTASSIUM USP | 2021-06-30 | Active | II | N/A |
