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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 | Apotex Pharmachem |
Canada |
APOTEX PHARMACHEM INDIA PVT LTD | 27923 | ETRAVIRINE | 2014-03-07 | Inactive | II | N/A | ||
28/03/2025 | Hetero Drugs |
India |
HETERO LABS LTD | 35835 | ETRAVIRINE PREMIX | 2021-06-15 | Active | II | Complete | 2021-07-20 | 2021-06-17 |