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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | PMC Isochem |
France |
PMC ISOCHEM | 7453 | LOPERAMIDE HYDROCHLORIDE | 1988-04-28 | Active | II | N/A | ||
28/10/2024 | Johnson & Johnson Innovative Medicine |
U.S.A |
JANSSEN PHARMACEUTICA NV | 10942 | LOPERAMIDE HYDROCHLORIDE | 1994-06-17 | Inactive | II | N/A |
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