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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 | Fareva |
Luxembourg |
EXCELLA GMBH AND CO KG | 15567 | GANCICLOVIR | 2001-07-31 | Active | II | Complete | 2013-01-30 | 2013-01-08 |
28/10/2024 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 31402 | GANCICLOVIR USP | 2017-02-18 | Active | II | Complete | 2017-03-07 | 2017-02-15 |
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