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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 |
TAPI NL BV | 17908 | FAMCICLOVIR | 2004-12-16 | Active | II | Complete | 2012-11-23 | 2012-11-08 |
28/03/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 22204 | FAMCICLOVIR USP | 2008-11-19 | Active | II | N/A |