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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
28/10/2024 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 35344 | RABEPRAZOLE SODIUM | 2020-11-27 | Active | II | Complete | 2023-08-17 | 2023-07-17 |
28/10/2024 | Dr. Reddy\'s Laboratories |
India |
DR REDDYS LABORATORIES LTD | 16747 | RABEPRAZOLE SODIUM HYDRATE (FORM Y) USP | 2003-08-04 | Active | II | N/A |
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