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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 |
---|---|---|---|---|---|---|---|---|---|---|---|
26/09/2024 | Biophore India Pharmaceuticals Pvt Ltd |
India |
BIOPHORE INDIA PHARMACEUTICALS PVT LTD | 33420 | GADOBUTROL MONOHYDRATE | 2019-09-10 | Active | II | Complete | 2020-08-04 | 2020-06-23 |
26/09/2024 | Bayer AG |
Germany |
BAYER AG | 13061 | GADOBUTROL | 1998-07-07 | Active | II | N/A |
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