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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 | Pharmathen SA |
Greece |
PHARMATHEN SA | 31546 | VALGANCICLOVIR HYDROCHLORIDE | 2017-05-12 | Active | II | Complete | 2017-11-07 | 2017-04-28 |
28/10/2024 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 26314 | VALGANCICLOVIR HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) | 2012-08-24 | Active | II | Complete | 2015-11-16 | 2015-11-10 |
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