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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 | TAPI Technology & API Services |
Israel |
FLAMMA SPA | 17794 | VALACYCLOVIR HYDROCHLORIDE | 2004-10-25 | Active | II | N/A | ||
28/03/2025 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INDIA PVT LTD | 21487 | VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE USP | 2008-04-01 | Active | II | N/A |