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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 25/04/2025 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INDIA PVT LTD | 24305 | ENTECAVIR USP | 2010-10-19 | Inactive | II | N/A | ||
| 25/04/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 27401 | ENTECAVIR | 2013-08-31 | Active | II | Complete | 2013-10-10 | 2013-08-27 |
