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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 | Disphar International |
Netherlands |
DISPHAR INTL BV | 19593 | BETAHISTINE.2HCL, 8MG AND 16MG TABLETS | 2006-06-23 | Inactive | II | N/A | ||
| 28/03/2025 | Henan Purui Pharmaceutical |
China |
HENAN PURUI PHARMACEUTICAL CO LTD | 36103 | BETAHISTINE HYDROCHLORIDE | 2021-07-14 | Active | II | N/A |
