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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
26/09/2024 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INDIA PVT LTD | 21487 | VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE USP | 2008-04-01 | Active | II | N/A | ||
26/09/2024 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 21688 | VALACYCLOVIR HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE) | 2008-06-07 | Active | II | Complete | 2014-04-18 | 2014-04-10 |
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