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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 29/07/2025 | Maithri Drugs |
India |
MAITHRI LABORATORIES PRIVATE LTD | 41583 | BETAHISTINE HYDROCHLORIDE USP | 2025-03-29 | Active | II | N/A | ||
| 29/07/2025 | Disphar International |
Netherlands |
DISPHAR INTL BV | 19593 | BETAHISTINE.2HCL, 8MG AND 16MG TABLETS | 2006-06-23 | Inactive | II | N/A |
