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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
04/06/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 35390 | OMEPRAZOLE MAGNESIUM | 2020-11-20 | Active | II | Complete | 2024-06-24 | 2024-05-23 |
04/06/2025 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 17706 | OMEPRAZOLE MAGNESIUM | 2004-09-24 | Active | II | N/A |