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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 | Arch Pharmalabs |
India |
ARCH PHARMALABS LTD | 22162 | NEVIRAPINE ANHYDROUS USP | 2008-11-05 | Inactive | II | N/A | ||
28/03/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 24520 | NEVIRAPINE ANHYDROUS USP (PROCESS II) | 2011-01-17 | Active | II | Complete | 2015-05-01 | 2015-04-09 |