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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 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 21974 | EPINASTINE HCL | 2008-12-30 | Active | II | N/A | ||
| 31/10/2025 | Boehringer Ingelheim GmbH |
Germany |
BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG | 15003 | EPINASTINE HYDROCHLORIDE | 2000-09-11 | Active | II | N/A |
