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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 | PMC Isochem |
France |
PMC ISOCHEM | 7453 | LOPERAMIDE HYDROCHLORIDE | 1988-04-28 | Active | II | N/A | ||
28/03/2025 | TAPI Technology & API Services |
Israel |
TEVA PHARMACEUTICAL INDUSTRIES LTD | 7340 | LOPERAMIDE HYDROCHLORIDE | 1988-02-17 | Active | II | Complete | 2017-01-19 | 2016-11-28 |