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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 | Inke S.A |
Spain |
INKE SA | 26694 | OLANZAPINE | 2013-01-24 | Active | II | Complete | 2014-03-03 | 2013-01-23 |
| 28/03/2025 | Neuland Laboratories |
India |
NEULAND LABORATORIES LTD | 19282 | OLANZAPINE FORM-1 USP | 2006-03-24 | Active | II | N/A |
